# K920793: Philips Dsi System Release 3.2

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jul 17, 1992 after 147 days
- Product code: IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot)
- Device class: 2
- Regulation: 21 CFR 892.1620
- Recalls of this device: 2 (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
- K023440: Philips Digital Imaging Option Release 1 (2002), 0 descendants of its own

## Recalls of this device
- May 23, 2008 · Not classified · Z-2160-2008: X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
- Jan 4, 2008 · Not classified · Z-2406-2010: Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.

Source page: https://510kreport.com/device/K920793
Methodology: https://510kreport.com/methodology