# K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Nov 20, 2012 after 183 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- 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 K862120 (1986). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis, GE Healthcare (2005) Summary page 3.
- K093427: FDR Acselerate System, DR-ID 200 Flat Panel Detector, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 2.

## Most influential descendants
- K152244: RADspeed Pro (2016), 3 descendants of its own
- K173517: RADspeed fit (2018), 1 descendant of its own
- K152294: FDR Visionary Suite (2016), 1 descendant of its own
- K233719: FDR Visionary Suite (2024), 0 descendants of its own
- K233722: RADspeed Pro (2024), 0 descendants of its own

## Indications for use
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.

Source page: https://510kreport.com/device/K121499
Methodology: https://510kreport.com/methodology