# K982706: Philips BV300 Series Release 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Sep 2, 1998 after 29 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K953910 (1995). 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)
- K953910: Philips BV 300 Series, Philips Medical Systems North America, Inc. (1995) Summary page 1.

## Indications for use
The Philips BV 300 Series Release 2.1 systems are Mobile C-Arm X-Ray Systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. The series has been designed primarily for use in the operating theater. The Philips BV300 Series Release 2.1 systems are intended for the same applications as the BV300 Series Release 1, i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room. This includes cerebral, thoracic, abdominal, peripheral, orthopedic and vascular procedures. The systems are also suited as a back-up for a fixed vascular X-ray system.

Source page: https://510kreport.com/device/K982706
Methodology: https://510kreport.com/methodology