TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C

K982427 · Trex Medical Corp. · OWB · Sep 23, 1998 · Radiology

Device Facts

• Record ID: K982427
• Device Name: TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
• Applicant: Trex Medical Corp.
• Product Code: OWB · Radiology
• Decision Date: Sep 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

Device Story

The TREX Tilt-C is an integrated C-arm and table system for radiographic and fluoroscopic imaging. It functions as a multipurpose positioning system for interventional and limited angiographic procedures. The device is operated by clinicians in a clinical setting to facilitate patient positioning during X-ray imaging. It provides an all-digital platform to support various diagnostic and interventional workflows, assisting healthcare providers in visualizing internal structures for clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Integrated C-arm and table multipurpose radiographic/fluoroscopic positioning system. All-digital imaging architecture. Classified under 21 CFR 892.1650 as an image-intensified fluoroscopic X-ray system (Product Codes OWB and JAA).

Indications for Use

Indicated for patients requiring radiographic, fluoroscopic, interventional, or limited angiographic procedures using an all-digital multi-purpose positioning system.

Regulatory Classification

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. William Cousins Vice President, Regulatory Affairs TREX Medical Corporation Continental Subsidiary 2000 South 25th Avenue BROADVIEW IL 60153

MAY = 7 2012

Re: K982427

Trade/Device Name: TREX Tilt-C, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 2, 1998 Received: July 2, 1998

Dear Mr. Cousins:

This letter corrects our substantially equivalent letter of September 23, 1998.

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{1}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATION OF USE

- "Indication For Use" page, for 510(K) Premarket Notification Submission for Re: TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system
510(k) Number:

## Device Name:

Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C.

## Indication For Use:

TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

TREX Medical Corporation, CONTINENTAL Division

O.Kluher

Oscar Khutoryansky, Vice President, Engineering July 2, 1998

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Concurrence of SDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Optional Format 1-2-96

David A. Bergman

(Division Sign-Off) Page-2 Division of Reproductive. Abdominal, ENT and Radiological D 510(k) Number