# K983069: Philips Duo Diagnost

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Nov 2, 1998 after 61 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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
Longest line of descent: 1 generation back to K912470 (1991). 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)
- K912470: Philips Diagnost 96, Philips Medical Systems, Inc. (1991) Summary page 1.

## Recalls of this device
- Dec 26, 2011 · Not classified · Z-1220-2012: The device is currently not compliant with FDA's amended design criteria for this system, the product is not commercially available in the US. However, it was inadvertently shipped to Puerto Rico due 

## Indications for use
The Philips DUO DIAGNOST is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

Source page: https://510kreport.com/device/K983069
Methodology: https://510kreport.com/methodology