FDA 510(k)

Zap-X Radiosurgical System

K-Number: K211663 · 2021-07-29

Decision Date2021-07-29

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Zap-X Radiosurgical System is a medical device manufactured by Zap Surgical Systems, Inc.. It received FDA 510(k) clearance on 2021-07-29 under approval number K211663. 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 Radiosurgical System?

Zap-X Radiosurgical System is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by Zap Surgical Systems, Inc.. The 510(k) number is K211663.

When was Zap-X Radiosurgical System approved by the FDA?

Zap-X Radiosurgical System received FDA 510(k) clearance on 2021-07-29, under approval number K211663.

What company makes Zap-X Radiosurgical System?

Zap-X Radiosurgical System is manufactured by Zap Surgical Systems, Inc..

What is the FDA product code for Zap-X Radiosurgical System?

The FDA product code for Zap-X Radiosurgical System is IYE.

Other Devices by Zap Surgical Systems, Inc.

K250392ZAP-X Radiosurgery System (ZAP-X)

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

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.