510(k) K131689
K131689 is an FDA 510(k) premarket notification submitted by C4 Imaging, LLC for the device "MRI MARKER". The FDA issued a decision of Substantially Equivalent on November 20, 2013. 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
- November 20, 2013
- Date Received
- June 10, 2013
- 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