# K122510: Icrco 3600M

- Pathway: 510(k) (Traditional)
- Applicant: Icrco, Inc.
- Decided: Apr 26, 2013 after 252 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- 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
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softeopy display at a workstation.

Source page: https://510kreport.com/device/K122510
Methodology: https://510kreport.com/methodology