July 28, 2022

Shimadzu Corporation Medical Systems Division

℅ Daniel Kamm
Principal Engineer
Kamm & Associates
8870 Ravello Ct
NAPLES FL 34114

Re: K221922
Trade/Device Name: Trinias
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB
Dated: June 30, 2022
Received: July 1, 2022

Dear Daniel Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.33
Silver Spring, MD 20993
www.fda.gov
K221922 - Daniel Kamm Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Laurel M. Burk -S
2022.07.28
12:37:22 -04'00'
Laurel Burk, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices
and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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 510(k) Summary: 510(k) Number K221922

Shimadzu Corporation
1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, Japan
Registration Number: 8030233
Phone: +81-75-823-1305 Fax: +81-75-823-1377
Date Prepared: July 26, 2022
Contact: Koichi Kataoka, General Manager, Quality Assurance Department, Medical Systems Division

1. Identification of the Device:

Trade/Device Names: Trinias
Regulation Number: 21CFR892.1650
Regulation Name: Image-intensified fluoroscopic x-ray system
Regulatory Class: II
Product Code: OWB
Common/Usual Name: Interventional Fluoroscopic X-Ray System

2. Equivalent legally marketed device: K203535

Trade/Device Name: Trinias
Manufacturer: Shimadzu.
Regulation Number: 21CFR892.1650
Regulation Name: Image-intensified fluoroscopic x-ray system
Regulatory Class: II
Product Code: OWB
Common/Usual Name: Interventional Fluoroscopic X-Ray System

3. Indications for Use: The Trinias is an angiographic X-ray system which is used for diagnostic imaging
and interventional procedures. The Trinias is intended to be used for cardiac angiography,
neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography,
multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

4. Description of the Device: This notification is for a modified device. The modification is the addition of
the new MH-700 (ceiling mounted C-Arm). This is the functional equivalent of previous C-Arm MH-400.
All options declared under K203535 remain available. The Lateral Angiographic C-arm Support MH-700
allows examination of a patient by fluoroscopy or radiography from different angles with the patient
kept in a horizontal position in combination with a Frontal C-arm Support MH-600, an X-ray high voltage
unit, X-ray tube unit, X-ray image recording unit (FPD), digital angiography system, catheterization
table, etc. The range of available digital receptor panels remains unchanged from our predicate
K203535. For installation, ceiling strength is important because the total weight of MH-700 exceeds
1200 kg. The MH-700 features faster movement speeds as compared to the previous model, the MH-
400.

5. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing
indicates that the modified device is as safe and effective as the predicate device. Proper system
operation is fully verified upon installation. Most of the components employed are identical to the
predicate device.
Page | 1
6. Substantial Equivalence Chart: Below.
Trinias K203535 Modified Trinias
Indications for The Trinias is an angiographic X-ray system The Trinias is an angiographic X-ray system
Use: which is used for diagnostic imaging and which is used for diagnostic imaging and
interventional procedures. The Trinias is interventional procedures. The Trinias is
intended to be used for cardiac angiography, intended to be used for cardiac angiography,
neurovascular angiography, abdominal neurovascular angiography, abdominal
angiography, peripheral angiography, rotational angiography, peripheral angiography,
angiography, multi-purpose angiography and rotational angiography, multi-purpose
whole body radiographic/fluoroscopic angiography and whole body
procedures. radiographic/fluoroscopic procedures.
Indications statement has not changed.
Patient Table KS-100, table top can tilt. Same as predicate

Bi-plane C-Arms
Biplane C-arm MH-300 plus MH-400 MH-600 plus MH-700 (MH-700 is new)
(Combines a (MH-600 previously cleared)
floor mounted C-
arm with a ceiling
mounted C-arm)
Picture of MH-300/MH-400 MH-600/MH-700
equivalent
assembly

Comparison of Equivalent Assemblies: MH-400 vs MH-700

Lateral C-arm MH-400 (K123508) MH-700
Mounting Ceiling Same
Variation of LL position / RL Position Same
position
LL position "LAO120 - PA0 "LAO120 - PA0
Primary angle) Max 15deg/sec" Max 25deg/sec" Faster response
C-arm rotation (LAO=Left Anterior Oblique)
range and Speed (PA= Postero-Anterior projection)
RL position "PA0 - RAO120 "PA0 - RAO120
Primary angle) Max 15deg/sec" Max 25deg/sec" Faster response
C-arm rotation (RAO= Right Anterior Oblique)
range and Speed

Page | 2
 Trinias K203535 Modified Trinias
LL position "CRAN45 - CAUD45 "CRAN45 - CAUD45
Secondary Max 15deg/sec" Max 25deg/sec"
Angle C-arm (CRAN=Caudo-Cranial projection) Faster response
rotation range (CAUD=Cranio-Caudal projection)
and Speed
RL position "CRAN30°～CAUD30° "CRAN45 - CAUD45
Secondary Angle Max 15deg/sec" Max 25deg/sec"
C-arm rotation Faster response
range and Speed
SID range/speed 95cm - 125cm , 8cm/sec max 95cm - 125cm, 10cm/sec max
Faster response
Digital Image DAR-9500f Same as predicate
Processor
Digital X-Ray Receptor Panels (No changes) Shimadzu Reference/Manufacturer Model
SIZE: 8" x 8" SFD-0808AF Varex PaxScan 2020X (194µm) Same as predicate
SIZE: 12" x 12" SFD-1212AF Varex PaxScan 3030X (194µm Same as predicate
SIZE: 16" x 12" SFD-1612AF Varex PaxScan 4030X (194µm) Same as predicate
X-Ray Generation
Generator 100 kW Same as predicate
Model # D150GC-40 Same as predicate
Control Method 50 kHz Inverter Same as predicate
Rated output 100 kW Same as predicate
Radiography 40 kV- 150 kV
Same as predicate
tube Voltage
Radiography 10 to 1250 mA
Same as predicate
tube current
Radiography mAs 0.5 to 800 mAs Same as predicate
Radiography time 0.001 to 10 sec Same as predicate
Fluoroscopy tube 50 kV to 125 kV
Same as predicate
voltage
Fluoroscopy tube 0.3 to 38 mA
Same as predicate
current
Short time rating 100 kV – 1000 mA Same as predicate
Long time rating 100 kV - 38mA Same as predicate
F-100: Has 16 BH filters with irridation area of
Collimator 421 x 421 mm max. New collimator offers Same as predicate
more filtration options.
US Performance 21CFR1020.30, 21CFR1020.31 and
Same as predicate
Standard 21CFR2020.32
IEC Safety
See list below Same as predicate
Standards

Page | 3
7. Summary of non-clinical testing: Software was validated according to the FDA Guidance: Guidance for
the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on:
May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations
contained in the FDA Guidance Document: Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff
Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by
FDA. Labeling was developed and information provided in accordance with this FDA Guidance
Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for
Industry and Food and Drug Administration Staff, November 2017. Labeling also includes reference to
the Image Gently website (http://www.imagegently.org/). Because the device contains wireless
technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidance for
Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling.

This device has been tested and is certified to comply with the US Radiation Safety Performance
Standards as listed in the table above. Performance and safety testing was conducted by third party
NRTL certified testing laboratories and the device was found to comply with the following FDA
recognized standards:
• US Performance Standard: 21CFR1020.30, 21CFR1020.31 and 21CFR2020.32
• IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 Medical electrical equipment - Part
1: General requirements for basic safety and essential performance FDA 19-4
• IEC 60601-1-2:2014 Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA
19-8
• IEC 60601-1-3:2008 + A1:2013 Medical electrical equipment - Part 1-3: General requirements for
basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-
ray equipment FDA 12-269
• IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability FDA 5-89
• IEC 60601-2-43:2010 +A1:2017 +A2:2019 Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures FDA 12-329
• Additionally evaluated in accordance with
• IEC 62366: 2007 + A1: 2014 Medical devices - Part 1: Application of usability engineering to medical
devices FDA 5-114
• IEC 62304: 2006 Medical device software - Software life cycle processes FDA 13-79
• EN 60601-1:2006 + A11:2011 + A1:2013 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
• EN 60601-1-3:2008 + A1:2013 + A11:2016 Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance - Collateral Standard: Radiation protection
in diagnostic X-ray equipment
• EN 60601-1-6:2010 + A1:2015 Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability
• EN 60601-2-43:2010 + A1:2018 Medical electrical equipment - Particular requirements for the basic
safety and essential performance of X-ray equipment for interventional procedures
• EN 62304:2006 Medical device software - Software life cycle processes
• ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012

Page | 4
 We consulted the following FDA guidance documents in the development of the Trinias:
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance
for Industry and Food and Drug Administration Staff; and Pediatric Information for X-ray Imaging
Device Premarket Notifications.

8. Summary of clinical testing: Not applicable. Clinical testing was not deemed to be required to show
substantial equivalence. We relied on non-clinical testing and compliance with standards.

9. Conclusion: After analyzing standards compliance results and bench tests, it is the conclusion of
Shimadzu Corporation that the MODIFIED Trinias is as safe and effective as the predicate device, has
few technological differences, and has the same indications for use, thus rendering it substantially
equivalent to the predicate device.

Page | 5