510(k) K182665
K182665 is an FDA 510(k) premarket notification submitted by Sensus Healthcare, Inc. for the device "Sensus TPS Workstation". The FDA issued a decision of Substantially Equivalent on February 21, 2019. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Sensus Healthcare, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2019
- Date Received
- September 25, 2018
- 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