RADspeed fit
FDA 510(k) K173517 · Shimadzu Corporation
510(k) numberK173517
Submission
- Device name
- RADspeed fit
- Applicant
- Shimadzu Corporation
Kyoto, JP - Received
- November 14, 2017
- Decision date
- March 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
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| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
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| K252099 | TriniasOWB · Abbreviated | 03/24/2026SE |
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| K233722 | RADspeed ProKPR · Traditional | 02/23/2024SE |
| K191877 | FLUOROspeedJAA · Special | 08/05/2019SE |
| K190373 | SonialVision G4JAA · Special | 03/15/2019SE |
| 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 |
| K123508 | TriniasOWB · Abbreviated | 02/26/2014SE |
Questions and answers
When was RADspeed fit cleared by the FDA?
RADspeed fit (K173517) received a 510(k) decision of Substantially Equivalent on March 30, 2018, 136 days after the submission was received.
What is the product code of K173517?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.