# K022710: Smartpacs

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Electronic Data Processing Corporation
- Decided: Oct 11, 2002 after 58 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 K002936 (2000). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002936: Modification to IDS5 Image Display System, Sectra-Imtec AB (2000)

## Most influential descendants
- K083182: Datacom DC Pacs (2009), 2 descendants of its own
- K082808: Imagesvr Pacs (2009), 1 descendant of its own
- K152034: FS-Pacs (2016), 0 descendants of its own
- K092125: Presidio Pacs (2009), 0 descendants of its own
- K042507: Ubipacs (2004), 0 descendants of its own

## Indications for use
The SmartPACSTMdevice is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

Source page: https://510kreport.com/device/K022710
Methodology: https://510kreport.com/methodology