# K033377: Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jan 9, 2004 after 79 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). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K012010: Modification to LR 5200 Film Recorder, Agfa Corp. (2001) Summary page 2.
- K002146: Kodak Dryview 8610 Laser Imager / for Mammography, Eastman Kodak Company (2000) Summary page 2.

## Most influential descendants
- K083522: Sony UP-DF750 Digital Film Imager (2009), 0 descendants of its own

## Indications for use
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.

Source page: https://510kreport.com/device/K033377
Methodology: https://510kreport.com/methodology