← Product Code [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB) · K123508

# TRINIAS (K123508)

_Shimadzu Corporation · OWB · Feb 26, 2014 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K123508

## Device Facts

- **Applicant:** Shimadzu Corporation
- **Product Code:** [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB.md)
- **Decision Date:** Feb 26, 2014
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1650
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended Use

The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFR 892.1650. The Trinias is intended to be used for cardiac angiography, abdominal angiography, abdominal angiography, peripheral angiography, rolational angiography, multi-purpose angiography and whole body radiographic filluoroscopic procedures. The Trinias is intended to be used for interventional procedures such as invasive cardiology and interventional neuroradiology.

## Device Story

Trinias is an image-intensified fluoroscopic X-ray system; used for diagnostic imaging and interventional procedures. Inputs: X-ray radiation; outputs: fluoroscopic and radiographic images. Operated by clinicians in clinical settings (e.g., cath labs, interventional suites). System supports invasive cardiology and neuroradiology. Output used by physicians for real-time visualization during procedures; aids clinical decision-making by providing anatomical guidance for interventions. Benefits include improved procedural accuracy and patient outcomes during minimally invasive vascular and cardiac procedures.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Image-intensified fluoroscopic X-ray system. Operates via X-ray generation and detection. Form factor includes X-ray tube, generator, and image intensifier assembly. Complies with 21 CFR 1000-1050 for electronic product radiation control. Connectivity includes standard imaging interfaces for display and storage.

## Regulatory Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2014

SHIMADZU Corporation % Mr. Don Karle Manager, Customer Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90202-1328

Re: K123508

Trade/Device Name: Trinias Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: February 7, 2014 Received: February 12, 2014

Dear Mr. Karle:

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. 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 11 (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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Karle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sm. 7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K123508

Device Name Trinias

Indications for Use (Describe)

- The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFR 892.1650.

- The Trinias is intended to be used for cardiac angiography, abdominal angiography, abdominal angiography, peripheral angiography, rolational angiography, multi-purpose angiography and whole body radiographic filluoroscopic procedures.

. The Trinias is intended to be used for interventional procedures such as invasive cardiology and interventional neuroradiology.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm7)

FORM FDA 3881 (9/13)

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K123508](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K123508)

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