# K971489: Ratational Angiography Option for Philips Multidiagnost 4

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Jul 3, 1997 after 71 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- 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 K923813 (1992). 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)
- K923813: Philips Integris V3000 Rotational Angio Function, Philips Medical Systems, Inc. (1992) Summary page 1.

## Indications for use
The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.

Source page: https://510kreport.com/device/K971489
Methodology: https://510kreport.com/methodology