# K093427: FDR Acselerate System, DR-ID 200 Flat Panel Detector

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jan 21, 2010 after 79 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System (2012), 6 descendants of its own
- 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

## Indications for use
The FDR AcSelerate system is a configurable stationary overhead X-ray tube and stand/table system intended to be used by a qualified/trained doctor or technologist for taking general radiographic and tomographic exposures of the whole body. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The FDR AcSelerate is not intended for mammography. The FDR AcSelerate uses an integrated digital detector for generating diagnostic images by converting X-rays into electronic signals.

Source page: https://510kreport.com/device/K093427
Methodology: https://510kreport.com/methodology