# K070123: TCA 5R / 5S

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Mar 9, 2007 after 52 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992103 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992103: C-Quest, Wuestec Medical, Inc. (1999) Summary page 1.
- K002198: Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile IQ, Model Tca 4R Plus, Fluoro Scan Imaging Systems, Inc. (2000) Summary page 1.

## Indications for use
The TCA 5R / 5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics, simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures.

Source page: https://510kreport.com/device/K070123
Methodology: https://510kreport.com/methodology