510(k) K223465
K223465 is an FDA 510(k) premarket notification submitted by Radiance Therapeutics, Inc. for the device "RadianceTx Radionuclide Brachytherapy Source". The FDA issued a decision of Substantially Equivalent on January 11, 2023. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2023
- Date Received
- November 17, 2022
- 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