# K961374: Philips Multidiagnost 4

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Aug 19, 1996 after 132 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K033486: GE Precision Mpi (2003), 1 descendant of its own
- K023441: Philips Multidiagnost Eleva (2002), 1 descendant of its own
- K173631: Intelli-C (2018), 0 descendants of its own
- K050151: Multidiagnost Eleva (2005), 0 descendants of its own

## Recalls of this device
- Jul 6, 2009 · Not classified · Z-1664-2009: The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
- Apr 6, 2006 · Not classified · Z-0852-06: Potential for unexpected table movement.
- Jan 10, 2003 · Not classified · Z-0586-03: INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT

## Indications for use
The MultiDIAGNOST 4 is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

Source page: https://510kreport.com/device/K961374
Methodology: https://510kreport.com/methodology