# K083555: Picture Archiving and Communication System (Pacs), Petavision

- Pathway: 510(k) (Traditional)
- Applicant: Emsoma Co., Ltd.
- Decided: Dec 16, 2008 after 14 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 K010259 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010259: Mediface Pacs, Mediface Co., Ltd. (2001)

## Most influential descendants
- K092081: Qxlink (2009), 2 descendants of its own
- K162868: Exam Vue PACS (2017), 1 descendant of its own
- K213520: Axir-CX (2022), 0 descendants of its own

## Indications for use
The PetaVision is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K083555
Methodology: https://510kreport.com/methodology