# K061028: Precision Thunis 800+

- Pathway: 510(k) (Abbreviated)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 7, 2006 after 55 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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 K943805 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943805: Prestige Remote R & F System Models H, VH & VHD, General Electric Co. (1994) Summary page 1.

## Indications for use
The Precision THUNIS 800+ is a digital remote R&F system intended to generate fluoroscopic and spot-film images of the patient during diagnostic procedures. The system is indicated also for use in generating radiographic images of human anatomy in general purpose diagnostic procedures. The system is not intended for mommographic or dental applications.

Source page: https://510kreport.com/device/K061028
Methodology: https://510kreport.com/methodology