Sirius MRI Marker NS
FDA 510(k) K171487 · C4 Imaging, LLC
510(k) numberK171487
Submission
- Device name
- Sirius MRI Marker NS
- Applicant
- C4 Imaging, LLC
Doylestown, PA, US - Received
- May 22, 2017
- Decision date
- August 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sirius MRI Marker NS cleared by the FDA?
Sirius MRI Marker NS (K171487) received a 510(k) decision of Substantially Equivalent on August 25, 2017, 95 days after the submission was received.
What is the product code of K171487?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.