Vertix 3D-U
FDA 510(k) K802200 · Siemens Corp.
510(k) numberK802200
Submission
- Device name
- Vertix 3D-U
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- September 11, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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 |
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Questions and answers
When was Vertix 3D-U cleared by the FDA?
Vertix 3D-U (K802200) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 42 days after the submission was received.
What is the product code of K802200?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.