# K013686: Kodak Directview Tabletop Cassette

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Dec 7, 2001 after 30 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.
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 its predicate without a number.
- (no number) cassettes associated with computed radiography systems marketed by Eastman Kodak Company: named in the summary without a submission number
- (no number) cassettes associated with computed radiography systems marketed by Fuji Medical Systems USA: named in the summary without a submission number
- (no number) cassettes associated with computed radiography systems marketed by Agfa Medical Imaging: named in the summary without a submission number

## Indications for use
KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

Source page: https://510kreport.com/device/K013686
Methodology: https://510kreport.com/methodology