# K964414: LR 5200 Laser Film Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp., Agfa Div.
- Decided: Jan 27, 1997 after 83 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices 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) Agfa LR 3300: named in the summary without a submission number
- (no number) Agfa Compact L: named in the summary without a submission number
- (no number) DuPont LP 400: named in the summary without a submission number
- (no number) Fuji FL-IMD: named in the summary without a submission number
- (no number) Polaroid Helios 1417: named in the summary without a submission number

## Most influential descendants
- K012010: Modification to LR 5200 Film Recorder (2001), 3 descendants of its own
- 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
- K972822: Imation SE-204 Laser Imager (1997), 0 descendants of its own

## Recalls of this device
- Nov 25, 2003 · Not classified · Z-0207-04: The GS1 circuit board may fail resulting in smoke or fire.

## Indications for use
The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities. The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.

Source page: https://510kreport.com/device/K964414
Methodology: https://510kreport.com/methodology