# K090469: Carestream Dryview 5850 Laser Imager

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: May 22, 2009 after 88 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 K002146 (2000). 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)
- K033821: Kodak Dryview 8900 Laser Imager Mammography Accessory, Eastman Kodak Company (2004) Summary page 1.

## Indications for use
The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

Source page: https://510kreport.com/device/K090469
Methodology: https://510kreport.com/methodology