Zap-X Radiosurgery System

GUDID 00860183001504

The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.

ZAP SURGICAL SYSTEMS, INC.

Stereotactic radiosurgery/radiation therapy linear accelerator system
Primary Device ID00860183001504
NIH Device Record Key5445cb38-3e97-4a59-b73e-7de2f38e243c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZap-X Radiosurgery System
Version Model Number300150
Company DUNS082344400
Company NameZAP SURGICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860183001504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-29

Devices Manufactured by ZAP SURGICAL SYSTEMS, INC.

00860183001504 - Zap-X Radiosurgery System2018-10-01The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
00860183001504 - Zap-X Radiosurgery System2018-10-01 The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radi
00860183001511 - Zap-X Treatment Delivery Software2018-10-01 The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com
00860183001528 - Zap-X Treatment Planning Software2018-10-01 The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com
00860183001535 - Zap-X MV Imager2018-10-01 The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled s

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