# K161518: Pacs Core/Encore

- Pathway: 510(k) (Traditional)
- Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Decided: Aug 17, 2016 after 76 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 K092949 (2009). 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)
- K092949: Imagegrid Radiology Viewer System, Candelis, Inc. (2009) Summary page 4.

## Indications for use
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K161518
Methodology: https://510kreport.com/methodology