# K984111: FV-RF

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Dec 11, 1998 after 24 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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
- K012424: Shimadzu Image Amplifier Model # IA-16LM (2001), 0 descendants of its own

## Recalls of this device
- Nov 18, 2016 · Class II · Z-1005-2017: There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause

## Indications for use
Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.

Source page: https://510kreport.com/device/K984111
Methodology: https://510kreport.com/methodology