510(k) · Cleared
ClearedFDR Acselerate System, DR-ID 200 Flat Panel Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 21, 2010 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jan 21, 2010
- Review
- 79 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK093427 FDR Acselerate System, DR-ID 200 Flat Panel DetectorFujifilm Medical System U.S.A., Inc. · 2010
- Descendant · cites it directly · 6 of its ownK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 3 of its ownK152244 RADspeed ProShimadzu Corporation · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK173517 RADspeed fitShimadzu Corporation · 2018
- Descendant · cites it directly · 1 of its ownK152294 FDR Visionary SuiteShimadzu Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK233719 FDR Visionary SuiteShimadzu Corporation · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly6descendants
- K152244RADspeed ProShimadzu Corporation · 2016 · cites it directly3descendants
- K173517RADspeed fitShimadzu Corporation · 2018 · 2 generations on1descendant
- K152294FDR Visionary SuiteShimadzu Corporation · 2016 · cites it directly1descendant
- K233719FDR Visionary SuiteShimadzu Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093427 | FDR Acselerate System, DR-ID 200 Flat Panel Detector | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| +1 | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K152244 | RADspeed Pro | Shimadzu Corporation | 2016 | 2 |
| +2 | K173517 | RADspeed fit | Shimadzu Corporation | 2018 | — |
| +1 | K152294 | FDR Visionary Suite | Shimadzu Corporation | 2016 | 5 |
| +2 | K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121499 (Fujifilm Medical System U.S.A., Inc., 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093427 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093427: FDR Acselerate System, DR-ID 200 Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026