510(k) K253091
K253091 is an FDA 510(k) premarket notification submitted by Therapanacea Sas for the device "ART-Plan+ (v3.1.0)". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Therapanacea Sas has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2025
- Date Received
- September 23, 2025
- 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