510(k) K243057
K243057 is an FDA 510(k) premarket notification submitted by Adaptiiv Medical Technologies, Inc. for the device "TrueFit Bolus; TrueFlex Bolus". The FDA issued a decision of Substantially Equivalent on October 23, 2024. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Adaptiiv Medical Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2024
- Date Received
- September 27, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type