510(k) K171804
K171804 is an FDA 510(k) premarket notification submitted by Zap Surgical Systems for the device "Zap-X Radiosurgery System". The FDA issued a decision of Substantially Equivalent on September 21, 2017. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Zap Surgical Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2017
- Date Received
- June 19, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type