# K973125: Mammoloader by C.M.a. SRL

- Pathway: 510(k) (Traditional)
- Applicant: C.M.A.
- Decided: Oct 8, 1997 after 49 days
- Product code: IXW (Processor, Radiographic-Film, Automatic)
- Device class: 2
- Regulation: 21 CFR 892.1900
- 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 K905607 (1991). 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)
- K905607: Kodak X-Omat Multiloader 300, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
The MAMMOLQOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions. Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

Source page: https://510kreport.com/device/K973125
Methodology: https://510kreport.com/methodology