Fiducial Marker
FDA 510(k) K211590 · Carbon Medical Technologies, Inc.
510(k) numberK211590
Submission
- Device name
- Fiducial Marker
- Applicant
- Carbon Medical Technologies, Inc.
St. Paul, MN, US - Received
- May 24, 2021
- Decision date
- June 10, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K133148 | Biomarc Coaxial NeedleFBK · Traditional | 05/13/2014SE |
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| K132708 | Biomarc Fiducial MarkerNEU · Traditional | 12/20/2013SE |
| K130678 | Biomarc Gold Fiducial MarkerIYE · Special | 04/12/2013SE |
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Questions and answers
When was Fiducial Marker cleared by the FDA?
Fiducial Marker (K211590) received a 510(k) decision of Substantially Equivalent on June 10, 2021, 17 days after the submission was received.
What is the product code of K211590?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.