# K173517: RADspeed fit

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corporation
- Decided: Mar 30, 2018 after 136 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: 11 generations back to K981556 (1998). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152244: RADspeed Pro, Shimadzu Corporation (2016) Summary page 4.
- K170332: Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless, Canon, Inc. (2017) Summary page 4.

## Most influential descendants
- K220518: Skanrad 400 (2022), 0 descendants of its own

## Indications for use
The RADspeed fit 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 fit enables radiographic exposure 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 fit 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 device is not intended for mammographic applications or tomographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique. WARNING: United States Federal Law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K173517
Methodology: https://510kreport.com/methodology