FDA.reportPublic FDA data

Zap-X MV Imager

Primary DI
00860183001535
Brand
Zap-X MV Imager
Company
ZAP SURGICAL SYSTEMS, INC.
Model
300153
Device description
The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
Published
2018-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171804000Zap-X Radiosurgery SystemZap Surgical Systems2017-09-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860183001535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860183001535008601830015358601830015350860183001535

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgery/radiation therapy linear accelerator systemA stationary assembly of computer-based devices designed to produce high-energy electrons to yield high-energy x-rays used to perform stereotactic radiosurgery (SRS) to treat brain, neck, or spinal cord tumours, and/or to perform stereotactic body radiation therapy (SBRT). It consists of a linear accelerator with a moveable/rotating gantry, collimators, patient table, and an operator's console. A metal head frame attached to the patient's skull may be used for precise radiation beam targeting using fiducial references; the system may include CBCT-based image-guided radiation therapy (IGRT), 3-D imaging, and record/verify functionalities to track target location during treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082344400
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014658303PinZ Patient Immobilizer4658302025-11-17
00860183001542Kit, Container, Head Immobilizer3001542025-11-17
00860183001573ZAP-Axon Treatment Planning System3001572025-11-17
00860183001580DoseGuard3001582025-11-17
00860183001597Kit, Container, Fixation Pins, Immobilizer3001592025-11-17
00860183001504Zap-X Radiosurgery System3001502018-08-29
00860183001511Zap-X Treatment Delivery Software3001512018-08-29
00860183001528Zap-X Treatment Planning Software3001522018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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