# K073169: Scimage Picomenterprise

- Pathway: 510(k) (Traditional)
- Applicant: Scimage, Inc.
- Decided: Jan 9, 2008 after 61 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960911: Netra Workstation System & Netra MD Software, Scimage, Inc. (1996) Summary page 1.
- K003484: Netra Workstation and Netramd Software, Scimage, Inc. (2001) Summary page 1.
- K062477: Amicas Vision Series Pacs, Model 4.3, Amicas, Inc. (2006) Summary page 1.

## Indications for use
The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images. Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K073169
Methodology: https://510kreport.com/methodology