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ZAP-X Radiosurgery System

by Zap Surgical Systems, Inc. EUDAMED510(k)GUDID

Active European Union and United States

510(k) K250392Ref 300150Model ZAP-X

Overview

The ZAP-X Radiosurgery System is a Linear Accelerator, Medical designed for stereotactic radiosurgery (SRS). It delivers precise radiation therapy to treat tumors, lesions, and brain-related conditions, leveraging a self-shielded, dedicated platform to minimize off-target exposure and maximize treatment accuracy.

This system is supplied as a reusable, hospital-based device with MRI compatibility (non-ferromagnetic components) and is regulated under FDA 510K and MDR frameworks. It operates within a controlled clinical environment, requiring specialized training for operation and maintenance. Authorized for use in radiology settings, it adheres to 892.5050 regulatory standards for linear accelerators.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number860183001504PRODUCTIDX5 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250392 Date3 Nov 2025ClearedStatusActive
United StatesGUDID listing GUDID Number00860183001504 UDI-DIDate29 Aug 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Full name
ZAP-X Radiosurgery System (ZAP-X)
Trade Name
Zap-X Radiosurgery System
Generic Name
Stereotactic radiosurgery/radiation therapy linear accelerator system
Model / Reference
300150, ZAP-X
Primary DI / UDI-DI
00860183001504
Basic UDI-DI
860183001504PRODUCTIDX5
510(k) Number
FDA Product Code
IYE, MUJ
EMDN Code
Z11010701 Radiosurgery systems
GMDN Term
Stereotactic radiosurgery/radiation therapy linear accelerator system
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.5050
Market of Registration
Germany
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

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Questions

  • What types of medical conditions is the ZAP-X Radiosurgery System designed to treat?

    The ZAP-X Radiosurgery System is specifically designed for stereotactic radiosurgery (SRS), which delivers precise radiation therapy to treat tumors, lesions, and brain-related conditions. Its self-shielded, dedicated platform ensures minimal off-target exposure, maximizing accuracy for targeted treatments.

  • Is the ZAP-X Radiosurgery System intended for single-use or reusable applications in a hospital setting?

    The ZAP-X Radiosurgery System is supplied as a reusable, hospital-based device. It is designed for use in controlled clinical environments, requiring specialized training for both operation and maintenance.

  • Can the ZAP-X Radiosurgery System be used in conjunction with MRI equipment, and what precautions should be taken?

    Yes, the ZAP-X Radiosurgery System is MRI-compatible, featuring non-ferromagnetic components. However, since it operates within a controlled clinical environment, proper protocols must be followed to ensure compatibility and safety during concurrent or sequential use with MRI systems.

  • What regulatory pathways has the ZAP-X Radiosurgery System undergone, and where is it authorized for use?

    The ZAP-X Radiosurgery System has been authorized through the FDA 510K pathway and adheres to the MDR (Medical Device Regulation) framework. It is regulated under FDA standard 892.5050 and is intended for use in radiology settings, as indicated by its advisory committee classification.

  • How does the ZAP-X Radiosurgery System ensure precision and minimize off-target radiation exposure?

    The ZAP-X Radiosurgery System leverages a self-shielded, dedicated platform designed specifically for stereotactic radiosurgery. This specialized design helps to minimize off-target radiation exposure while delivering highly precise radiation therapy, ensuring accurate treatment of tumors, lesions, and brain-related conditions.

Properties

  • Serial Number

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No