510(k) K171487
K171487 is an FDA 510(k) premarket notification submitted by C4 Imaging, LLC for the device "Sirius MRI Marker NS". The FDA issued a decision of Substantially Equivalent on August 25, 2017. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. C4 Imaging, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2017
- Date Received
- May 22, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Brachytherapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type