# K012155: Kodak Radiation Oncology Software/ for Acr Systems

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Aug 10, 2001 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952914 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980213: DI-2000, Lumisys, Inc. (1998) Summary page 1.

## Indications for use
Kodak Radiation Oncology Software / for ACR systems is intended to utilize a scanner and software interface to digitize computed radiography exposed phosphor plates. Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application. Kodak Radiation Oncology Software / for ACR systems is enables, the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.

Source page: https://510kreport.com/device/K012155
Methodology: https://510kreport.com/methodology