# K192894: Vita Flex CR System with LLI

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: Feb 18, 2020 after 130 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960834 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073670: Kodak Point of Care CR 120, Kodak Point of Care  CR 140, Kodak Point of Care CR 260, Orex Computed Radiography, Ltd. (2008) Summary page 4.

## Indications for use
The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.

Source page: https://510kreport.com/device/K192894
Methodology: https://510kreport.com/methodology