510(k) K203146
K203146 is an FDA 510(k) premarket notification submitted by Akesis, Inc. for the device "Akesis Galaxy RTi". The FDA issued a decision of Substantially Equivalent on March 5, 2021. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Akesis, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2021
- Date Received
- October 21, 2020
- Clearance Type
- Traditional
- 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