# K022658: LR Dicom Controller

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Sep 6, 2002 after 28 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964414 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964414: LR 5200 Laser Film Recorder, Bayer Corp., Agfa Div. (1997) Summary page 1.
- K012010: Modification to LR 5200 Film Recorder, Agfa Corp. (2001)

## Indications for use
The LR 5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.

Source page: https://510kreport.com/device/K022658
Methodology: https://510kreport.com/methodology