# K083658: Pacs Plus 5TH Edition

- Pathway: 510(k) (Traditional)
- Applicant: Medical Standard Co., Ltd.
- Decided: Jul 7, 2009 after 209 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: 4 generations back to K010259 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042311: Pacspartner, Medical Standard Co., Ltd. (2004) Summary page 2.

## Indications for use
PACS PLUS 5 th EDITION is software that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K083658
Methodology: https://510kreport.com/methodology