# K051127: Kika Imaging Lab Viewer, Model 2.0.1.0

- Pathway: 510(k) (Traditional)
- Applicant: Kika Medical, Inc.
- Decided: Jun 3, 2005 after 31 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: 5 generations back to K896095 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- (no number) UltrPro PACs: named in the summary without a submission number

## Indications for use
KIKA Imaging Lab is intended to be used for diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-ray images, including manipulation, compression and quantification of images. The KIKA Imaging Lab brings is typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K051127
Methodology: https://510kreport.com/methodology