Zap-X Radiosurgery System

FDA 510(k) K183698 · Zap Surgical Systems

Substantially Equivalent

510(k) numberK183698

Submission

Device name
Zap-X Radiosurgery System
Applicant
Zap Surgical Systems
San Carlos, CA, US
Received
December 31, 2018
Decision date
February 25, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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More from Varian Medical Systems, Inc.

510(k)DeviceDecision
K250392ZAP-X Radiosurgery System (ZAP-X)IYE · Traditional 11/03/2025SE
K211663Zap-X Radiosurgical SystemIYE · Traditional 07/29/2021SE
K171804Zap-X Radiosurgery SystemIYE · Traditional 09/21/2017SE

Questions and answers

When was Zap-X Radiosurgery System cleared by the FDA?

Zap-X Radiosurgery System (K183698) received a 510(k) decision of Substantially Equivalent on February 25, 2019, 56 days after the submission was received.

What is the product code of K183698?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.