# K132499: Icrco Clarity Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Icrco, Inc.
- Decided: Jan 21, 2014 after 165 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations. Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mamnmographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation. Mamnmographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K132499
Methodology: https://510kreport.com/methodology