510(k) K180571
K180571 is an FDA 510(k) premarket notification submitted by Xcision Medical Systems, LLC for the device "GammaPod". The FDA issued a decision of Substantially Equivalent on April 4, 2018. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Xcision Medical Systems, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2018
- Date Received
- March 5, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5750
- Review Panel
- RA
- Submission Type