# K152244: RADspeed Pro

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corporation
- Decided: Jun 20, 2016 after 315 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862120 (1986). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093427: FDR Acselerate System, DR-ID 200 Flat Panel Detector, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 4.
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.
- K101686: FDR Image Stitching Option, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 4.
- K122454: Fujifilm Dual Energy Subtraction (Des) Software Option, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.

## Most influential descendants
- K173517: RADspeed fit (2018), 1 descendant of its own
- K233722: RADspeed Pro (2024), 0 descendants of its own
- K220518: Skanrad 400 (2022), 0 descendants of its own

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2294-2026: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
- May 23, 2017 · Class II · Z-2654-2017: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

## Indications for use
The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed Pro uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K152244
Methodology: https://510kreport.com/methodology