# K033624: Pacs Software Solution 2003

- Pathway: 510(k) (Special)
- Applicant: Canon USA, Inc.
- Decided: Dec 15, 2003 after 27 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940664 (1994). 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)
- K940664: Paper Film, Astro Office Products, Inc. (1994) Summary page 1.

## Indications for use
PACS Software Solution 2003 is used to acquire, process, display, evaluate, archive, print and distribute DICOM compliant images for clinical purposes. Images may be acquired from imaging modalities such as CR, CT, MR, X-Ray, and other devices.

Source page: https://510kreport.com/device/K033624
Methodology: https://510kreport.com/methodology