Digital Radiography System Radspeed Safire
FDA 510(k) K050925 · Shimadzu Corp.
510(k) numberK050925
Submission
- Device name
- Digital Radiography System Radspeed Safire
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- April 13, 2005
- Decision date
- June 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
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| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
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| K233722 | RADspeed ProKPR · Traditional | 02/23/2024SE |
| K191877 | FLUOROspeedJAA · Special | 08/05/2019SE |
| K190373 | SonialVision G4JAA · Special | 03/15/2019SE |
| K173517 | RADspeed fitKPR · Traditional | 03/30/2018SE |
| K152294 | FDR Visionary SuiteKPR · Traditional | 07/15/2016SE |
| K152244 | RADspeed ProKPR · Traditional | 06/20/2016SE |
| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
| K131075 | X-Ray TV System Sonial Vision G4JAA · Abbreviated | 03/28/2014SE |
Questions and answers
When was Digital Radiography System Radspeed Safire cleared by the FDA?
Digital Radiography System Radspeed Safire (K050925) received a 510(k) decision of Substantially Equivalent on June 1, 2005, 49 days after the submission was received.
What is the product code of K050925?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.