# K012010: Modification to LR 5200 Film Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Sep 20, 2001 after 85 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: 1 generation back to K964414 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K033377: Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L (2004), 1 descendant of its own
- K083522: Sony UP-DF750 Digital Film Imager (2009), 0 descendants of its own
- K022658: LR Dicom Controller (2002), 0 descendants of its own

## Indications for use
The LR5200 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/K012010
Methodology: https://510kreport.com/methodology