Zap-X Radiosurgery System
K-Number: K183698 · 2019-02-25
ApplicantZap Surgical Systems
Decision Date2019-02-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Zap-X Radiosurgery System is a medical device manufactured by Zap Surgical Systems. It received FDA 510(k) clearance on 2019-02-25 under approval number K183698. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zap-X Radiosurgery System?
Zap-X Radiosurgery System is a medical device that received FDA 510(k) clearance on 2019-02-25. It is manufactured by Zap Surgical Systems. The 510(k) number is K183698.
When was Zap-X Radiosurgery System approved by the FDA?
Zap-X Radiosurgery System received FDA 510(k) clearance on 2019-02-25, under approval number K183698.
What company makes Zap-X Radiosurgery System?
Zap-X Radiosurgery System is manufactured by Zap Surgical Systems.
What is the FDA product code for Zap-X Radiosurgery System?
The FDA product code for Zap-X Radiosurgery System is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.