# K251168: Image Suite

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Sep 4, 2025 after 142 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: 7 generations back to K954678 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140271: Tablet Viewer Software for Image Suite, Carestream Health, Inc. (2014) Summary page 6.

## Indications for use
Image Suite is a stand-alone radiographic imaging software designed to perform patient registration, review, report, archive, and print patient images. The software interacts with Carestream CR or DR to receive radiographic images for review, and has the ability to receive, archive, and review DICOM images from compatible third-party modalities (for example, US, MR, CT). The software can also update Carestream CR or DR device firmware and monitor device calibration. The software serves as a web server to support web clients for image viewing. Image Suite is intended for use by radiologists and trained healthcare professionals. The software presents images to medical professionals in a convenient digital medium so they can make diagnostic and/or therapeutic decisions. This excludes mammography applications and Tablet Viewer applications in the United States.

Source page: https://510kreport.com/device/K251168
Methodology: https://510kreport.com/methodology