Home GUDID 00860183001580 DoseGuard
Primary DI 00860183001580
Brand DoseGuard
Company ZAP SURGICAL SYSTEMS, INC.
Model 300158
Device description The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of patient safety by comparing measured and planned exit fluence and pausing the delivery if a deviation is detected.
Published 2025-11-17
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical MUJ System, Planning, Radiation Therapy Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2 MUJ System, Planning, Radiation Therapy Treatment Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860183001580 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860183001580 00860183001580 860183001580 0860183001580
GMDN Terms# Term, Definition table Term Definition Stereotactic radiosurgery/radiation therapy linear accelerator system A 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.
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