# K061972: Connect Imaging Pacs

- Pathway: 510(k) (Abbreviated)
- Applicant: Connect Imaging, Inc.
- Decided: Sep 18, 2006 after 67 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: 1 generation back to K031704 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031704: Filmless Clinic, Connect Imaging, Inc. (2003) Summary page 1.

## Indications for use
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol. Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specification reviewed and accepted by FDA. Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.

Source page: https://510kreport.com/device/K061972
Methodology: https://510kreport.com/methodology