# K083522: Sony UP-DF750 Digital Film Imager

- Pathway: 510(k) (Traditional)
- Applicant: Sony Electronics, Inc.
- Decided: Jan 9, 2009 after 44 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: 4 generations back to K002146 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072680: Drystar Axys, Model EYZ4E, Agfa Healthcare Corporation (2007) Summary page 1.
- K012941: Drystar, Model 4500M, Agfa Corp. (2001) Summary page 1.
- K033377: Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 1.
- K033821: Kodak Dryview 8900 Laser Imager Mammography Accessory, Eastman Kodak Company (2004) Summary page 1.
- K042133: Dry Laser Imager, Model  Drypro Model 793, Konica Minolta Medical & Graphic, Inc. (2004) Summary page 1.
- K024188: UP-DF500 Filmstation Digital Film Imager, Sony Medical Systems (2003) Summary page 1.

## Indications for use
The Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing medical diagnostic images from mammography systems. The UP-DF750 is a multi-format imager and also is intended for printing high-resolution diagnostic images from CT, MRI, CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended for use by medical radiologists or other appropriately trained medical personnel.

Source page: https://510kreport.com/device/K083522
Methodology: https://510kreport.com/methodology
