# K955268: PQ-2000+ Computed Tomography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jan 30, 1996 after 74 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982010: FACTS (1998), 0 descendants of its own

## Recalls of this device
- Mar 23, 2004 · Not classified · Z-0957-05: Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.

Source page: https://510kreport.com/device/K955268
Methodology: https://510kreport.com/methodology