Definium Tempo Select
FDA 510(k) K250788 · Ge Hualun Medical Systems Co. , Ltd.
510(k) numberK250788
Submission
- Device name
- Definium Tempo Select
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Beijing, CN - Received
- March 14, 2025
- Decision date
- August 28, 2025
- 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 |
| K250738 | YSIO X.preeKPR · Traditional | Siemens Medical Solutions | 07/31/2025SE |
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| K231892 | Definium Pace SelectKPR · Traditional | 09/12/2023SE |
| K191699 | Discovery XR656 HD with VolumeRadKPR · Traditional | 07/24/2019SE |
| K182626 | OEC OneOXO · Traditional | 11/16/2018SE |
| K173612 | Optima XR646 HDKPR · Special | 12/11/2017SE |
| K172700 | OEC OneOWB · Traditional | 11/09/2017SE |
| K172869 | Discovery XR656 HDKPR · Special | 10/20/2017SE |
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Questions and answers
When was Definium Tempo Select cleared by the FDA?
Definium Tempo Select (K250788) received a 510(k) decision of Substantially Equivalent on August 28, 2025, 167 days after the submission was received.
What is the product code of K250788?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.