# K963914: CM & CM DS-7

- Pathway: 510(k) (Traditional)
- Applicant: Konica Medical Corp.
- Decided: Oct 8, 1997 after 373 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K053173: DS Cassette (2005), 0 descendants of its own

## Indications for use
A device containing X-ray film for use in diagnostic imaging procedures.

Source page: https://510kreport.com/device/K963914
Methodology: https://510kreport.com/methodology
