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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Zap Surgical Systems. It received FDA 510(k) clearance on 2019-02-25 under 510(k) 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. The listed applicant is Zap Surgical Systems. The 510(k) number is K183698.

When did Zap-X Radiosurgery System receive FDA 510(k) clearance?

Zap-X Radiosurgery System received FDA 510(k) clearance on 2019-02-25, under 510(k) number K183698.

Who is the listed applicant for Zap-X Radiosurgery System?

The FDA 510(k) record lists Zap Surgical Systems as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Zap Surgical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250392ZAP-X Radiosurgery System (ZAP-X)K211663Zap-X Radiosurgical SystemK171804Zap-X Radiosurgery System

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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