# K010762: Philips BV Libra

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Apr 2, 2001 after 19 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System (2010), 0 descendants of its own

## Recalls of this device
- Dec 14, 2010 · Not classified · Z-1603-2011: The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.

Source page: https://510kreport.com/device/K010762
Methodology: https://510kreport.com/methodology