# K140271: Tablet Viewer Software for Image Suite

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Apr 1, 2014 after 57 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: 6 generations back to K954678 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100094: Carestream Image Suite, Carestream Heatlh, Inc. (2010) Summary page 1.

## Most influential descendants
- K251168: Image Suite (2025), 0 descendants of its own

## Indications for use
CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. Tablet Viewer Software for Image Suite is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR, DR, CT, MR, and US. Tablet Viewer Software for Image Suite provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer. This excludes mammography applications in the United States.

Source page: https://510kreport.com/device/K140271
Methodology: https://510kreport.com/methodology