510(k) · Cleared
ClearedDigital Radiography System Radspeed Safire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jun 1, 2005 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK050925 Digital Radiography System Radspeed SafireShimadzu Corp. · 2005
- Descendant · cites it directly · 8 of its ownK052500 DAR-8000FShimadzu Medical Systems · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK131075 X-Ray TV System Sonial Vision G4Shimadzu Corp. · 2014
- Descendant · 3 generations on · 5 of its ownK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK080859 DRF 4343Villa Sistemi Medicali S.P.A. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K052500DAR-8000FShimadzu Medical Systems · 2005 · cites it directly8descendants
- K131075X-Ray TV System Sonial Vision G4Shimadzu Corp. · 2014 · 2 generations on6descendants
- K142341X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · 3 generations on5descendants
- K190373SonialVision G4Shimadzu Corporation · 2019 · 4 generations on4descendants
- K080859DRF 4343Villa Sistemi Medicali S.P.A. · 2008 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050925 | Digital Radiography System Radspeed Safire | Shimadzu Corp. | 2005 | — |
| +1 | K052500 | DAR-8000F | Shimadzu Medical Systems | 2005 | 2 |
| +2 | K131075 | X-Ray TV System Sonial Vision G4 | Shimadzu Corp. | 2014 | — |
| +3 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| +4 | K190373 | SonialVision G4 | Shimadzu Corporation | 2019 | 2 |
| +1 | K080859 | DRF 4343 | Villa Sistemi Medicali S.P.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (15)
See all 153 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, K052500 (Shimadzu Medical Systems, 2005) has gone furthest, with 8 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.
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 digital radiography unit DAR-7000 is a radiographic system for a general acquisition using the flat panel sensor as X-ray detector. X-ray detector equipped with FPD (Flat Panel Detector) allows user to acquire a high-quality image. This system is designed to display digitizing the image, and to register or manipulate that image data. This unit is not used for mammography.
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/K050925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050925: Digital Radiography System Radspeed Safire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050925
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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