# K254237: Cci Pacs Viewer (Pacs-US-001)

- Pathway: 510(k) (Traditional)
- Applicant: CliniComp, Intl.
- Decided: Apr 23, 2026 after 115 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: 10 generations back to K942120 (1994). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203104: IBM iConnect Access, Merge Healthcare Incorporated (2021) Summary page 5.
- K222476: OmegaAI Image Viewer, Ramsoft, Inc. (2022) Summary page 5.

## Indications for use
The CCI PACS VIEWER is a software-based Medical Image Management and Processing System (MIMPS) intended to archive, distribute, retrieve, process, and display medical images and associated data from DICOM-compliant modalities and hospital information systems. The device provides healthcare professional tools to aid in the review, analysis, and interpretation of medical images through interactive display, manipulation, measurement, annotation, and comparison of images from supported modalities (CT, MR, PET, US, X-Ray). It is intended for use by trained and licensed healthcare professionals whose scope of practice includes the review or interpretation of medical images. This includes radiologists for primary diagnostic interpretation, and physicians or qualified medical technicians for clinical review, analysis, and consultation. Users must have completed appropriate training on the software’s functions, capabilities, and limitations. The system supports visualization and qualitative assessment of anatomical structures across images from major modalities, including spatial review within a single study and side-by-side or linked comparison of serial examinations. It is designed to assist healthcare providers in conjunction with primary diagnostics performed by a certified radiologist, or during direct consultation with a radiologist. The software is not intended to replace the independent skill, judgment, or diagnosis of a qualified medical practitioner. The device is not intended for primary diagnostic interpretation of mammography images or lossy compressed images that do not meet clinical quality requirements for the intended use. The CCI PACS VIEWER operates on a cloud-based virtual platform with a Windows operating system and is accessible via compliant HTML5 browsers on desktop, laptop, or mobile tablet devices. • For primary diagnostic interpretation, display monitors must be FDA-cleared for diagnostic use (where required by regulation) and maintained under a documented quality control program compliant with applicable standards. • CCI PACS VIEWER application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Source page: https://510kreport.com/device/K254237
Methodology: https://510kreport.com/methodology