Multitom Rax
FDA 510(k) K221281 · Siemens Medical Solutions
510(k) numberK221281
Submission
- Device name
- Multitom Rax
- Applicant
- Siemens Medical Solutions
Malvern, PA, US - Received
- May 3, 2022
- Decision date
- November 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K101749 | Syngo Trued SoftwareLLZ · Traditional | 08/16/2010SE |
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Questions and answers
When was Multitom Rax cleared by the FDA?
Multitom Rax (K221281) received a 510(k) decision of Substantially Equivalent on November 17, 2022, 198 days after the submission was received.
What is the product code of K221281?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.