# K152716: EV Insite System

- Pathway: 510(k) (Traditional)
- Applicant: Psp Corporation
- Decided: Mar 24, 2016 after 185 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: 7 generations back to K942120 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 5.

## Indications for use
EV Insite System by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K152716
Methodology: https://510kreport.com/methodology