510(k) K193640
K193640 is an FDA 510(k) premarket notification submitted by Radformation, Inc. for the device "ClearCalc". The FDA issued a decision of Substantially Equivalent on April 9, 2020. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Radformation, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2020
- Date Received
- December 27, 2019
- 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