# K070920: Fuji IP Cassette Type PC

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: May 22, 2007 after 50 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904519 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042779: Radiotherapy Solution Based on CR, Agfa Corp. (2004)
- K960834: Kodak EC-L Cassette, Eastman Kodak Company (1996) Summary page 1.

## Indications for use
The Fuji IP Cassette Type PC will be used as an accessory to megavoltage radiation therapy systems providing radiation therapy portal localization imaging and to aid in radiation therapy planning and quality control. The Fuji IP Cassette Type PC and imaging plate is a digital replacement technology for conventional film/cassette imaging systems.

Source page: https://510kreport.com/device/K070920
Methodology: https://510kreport.com/methodology