# K910115: Philips BV-29 Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Feb 20, 1991 after 41 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 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
- K963093: Siremobil Compact (1996), 23 descendants of its own
- K040066: Siremobile C06 (2004), 21 descendants of its own
- K051133: Arcadis Avantic (2005), 20 descendants of its own
- K132094: Cios Alpha (2014), 19 descendants of its own
- K153244: Cios Fusion (2016), 15 descendants of its own

## Recalls of this device
- Jul 20, 2004 · Not classified · Z-1456-04: Potential for c-arm to move due to loose screws
- Jul 20, 2004 · Not classified · Z-1453-04: Potential for c-arm to move due to loose screws
- Jul 20, 2004 · Not classified · Z-1457-04: Potential for c-arm to move due to loose screws

Source page: https://510kreport.com/device/K910115
Methodology: https://510kreport.com/methodology