# K953910: Philips BV 300 Series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Oct 18, 1995 after 58 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K982706: Philips BV300 Series Release 2.1 (1998), 0 descendants of its own

## Recalls of this device
- Sep 27, 2002 · Not classified · Z-0526-03: The C-bow support can bend and break allowing C-arm to fall from support

Source page: https://510kreport.com/device/K953910
Methodology: https://510kreport.com/methodology