510(k) K241318
K241318 is an FDA 510(k) premarket notification submitted by Adaptiiv Medical Technologies, Inc. for the device "Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)". The FDA issued a decision of Substantially Equivalent on August 30, 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
- August 30, 2024
- Date Received
- May 10, 2024
- Clearance Type
- Traditional
- 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