# K981280: CP 1000, Curix HT 330, Classic E.O.S., Curix HT 530, Mamoray HT 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp., Agfa Div.
- Decided: Apr 30, 1998 after 22 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
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. The FDA summary names no predicate by number.

## Indications for use
To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.

Source page: https://510kreport.com/device/K981280
Methodology: https://510kreport.com/methodology