510(k) K123985
K123985 is an FDA 510(k) premarket notification submitted by Sensus Healthcare for the device "SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100". The FDA issued a decision of Substantially Equivalent on May 14, 2013. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Sensus Healthcare has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2013
- Date Received
- December 26, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type