# K923813: Philips Integris V3000 Rotational Angio Function

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Oct 16, 1992 after 79 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964990: Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30) (1997), 1 descendant of its own
- K991231: Hitachi Versiflex (1999), 0 descendants of its own
- K990055: B-400 Ceiling Mounted Possitioner, Model B-400 (1999), 0 descendants of its own
- K971489: Ratational Angiography Option for Philips Multidiagnost 4 (1997), 0 descendants of its own

## Recalls of this device
- Oct 10, 2003 · Not classified · Z-0097-04: The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.

Source page: https://510kreport.com/device/K923813
Methodology: https://510kreport.com/methodology