Identifiers
- 510(k) Number
- K070123 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TCA 5R / 5S is an Interventional Fluoroscopic X-Ray System used in radiology. It is a Class II medical device that provides real-time imaging guidance during minimally invasive procedures.
The device is supplied as a reusable system and has received FDA 510(k) clearance under K-number K070123, granted on March 9, 2007. It is manufactured by Dornier MedTech America, Inc. and is intended for use in clinical radiology settings.
Frequently asked questions
What is the TCA 5R / 5S used for?
The TCA 5R / 5S is an Interventional Fluoroscopic X-Ray System used in radiology to provide real-time imaging guidance during minimally invasive procedures. It is intended for use in clinical radiology settings where fluoroscopic imaging supports diagnostic and interventional workflows.
Is the TCA 5R / 5S a reusable or single-use device?
The TCA 5R / 5S is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning, maintenance, and calibration in accordance with the manufacturer’s instructions. It is not intended for single-use disposal.
What regulatory pathway was used for the TCA 5R / 5S, and what is its classification?
The TCA 5R / 5S received FDA 510(k) clearance under K-number K070123, granted on March 9, 2007, and is classified as a Class II medical device. The 510(k) submission was based on a traditional review and found substantially equivalent to a predicate device.
Who manufactures the TCA 5R / 5S and where is it located?
The TCA 5R / 5S is manufactured by Dornier MedTech America, Inc., located at 1155 Roberts Blvd., Kennesaw, GA 30144, United States. The manufacturer’s FEI numbers and registration details are included in the device’s openFDA listing.
What product code and regulation number apply to the TCA 5R / 5S?
The TCA 5R / 5S is assigned product code OWB and regulation number 892.1650, which corresponds to Interventional Fluoroscopic X-Ray Systems under FDA classification. These codes are used for regulatory tracking and device categorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Proprietary Inc. - Food and Drug Administration, Dornier Medtech Tca 5R / 5S - allmed.wiki, TCA 5R / 5S (K070123) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070123 | Class II | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA 510(k) K070123 24 fields · synced Oct 6, 2026