# K061302: Digital Printer P6000D Series, Model P6000DU

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Electric Corporation Kyoto Works
- Decided: Jun 23, 2006 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: 3 generations back to K010275 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032635: Drystar 5300 Medical Image Printer, Model 5300, Agfa Corp. (2003) Summary page 2.

## Indications for use
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.

Source page: https://510kreport.com/device/K061302
Methodology: https://510kreport.com/methodology