# K063539: Nordic Image Control and Evaluation (Nice) Software, Version 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Nordicicemedical AS
- Decided: Jan 17, 2007 after 54 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.
75 later devices descend from it; 2 cite it directly.
0 of 82 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 2.

## Most influential descendants
- K082441: Nordicice Software (2008), 73 descendants of its own
- K090546: Modification to Nordicice Software (2009), 72 descendants of its own
- K111161: Perfscape V2.0 (2011), 53 descendants of its own
- K120196: Olea Sphere (2012), 51 descendants of its own
- K121447: Ischema View Rapid (2013), 29 descendants of its own

## Indications for use
Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Source page: https://510kreport.com/device/K063539
Methodology: https://510kreport.com/methodology