# K073650: Fujifilm Unity Speedsuite, Model CR-IR 371

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Feb 6, 2008 after 42 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 5 generations back to K981556 (1998). 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)
- K012546: Optima Urs Universal Radiographic System, Sedecal USA, Inc. (2001) Summary page 1.
- K033561: Fuji Computed Radiography (FCR) Velocity Image Reader, Fujifilm Medical System U.S.A., Inc. (2003) Summary page 1.
- K041990: Fuji Medical CR Console, Model Flash Iip, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 2.
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.

## Indications for use
FUJIFILM Unity SpeedSuite X-Ray System is Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K073650
Methodology: https://510kreport.com/methodology