# K981657: Philips Thoravision

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Jun 18, 1998 after 38 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931071 (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)
- K931071: Philips Thoravision, Philips Medical Systems, Inc. (1994) Summary page 2.

## Recalls of this device
- Dec 1, 2004 · Not classified · Z-0369-05: X-Ray system may fall downward and could possibly hit the patient.

## Indications for use
The Philips Thoravision is intended for use in general radiographic applications wherever conventional screen-film systems may be used.

Source page: https://510kreport.com/device/K981657
Methodology: https://510kreport.com/methodology