FDA.reportPublic FDA data

Zap-X Treatment Delivery Software

Primary DI
00860183001511
Brand
Zap-X Treatment Delivery Software
Company
ZAP SURGICAL SYSTEMS, INC.
Model
300151
Device description
The Zap-X Treatment Delivery Software 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
00860183001511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860183001511008601830015118601830015110860183001511

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

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
00860183001528Zap-X Treatment Planning Software3001522018-08-29
00860183001535Zap-X MV Imager3001532018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
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00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
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00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
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00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22