ZAP-Axon Treatment Planning System

Basic Information

• Brand Name: ZAP-Axon Treatment Planning System
• Primary DI: 00860183001573
• Version / Model: 300157
• Company Name: ZAP SURGICAL SYSTEMS, INC.
• Labeler DUNS: 082344400
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-17
• Public Version: 1
• Public Version Date: 2025-11-25
• Public Version Status: New
• Public Device Record Key: 8b1d1055-b0ba-4900-9763-3e2866895cd6

Device Description

The dedicated software application used to create, optimize, and review treatment plans for the ZAP-X Radiosurgery System. It provides the functionalities for the import, registration, and fusion of imaging studies, the delineation of target volumes and organs at risk (OARs), the calculation and optimization of the radiation dose, and the creation of planning reports. The application is installed on dedicated workstations that are directly connected to the other ZAP-X components.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18054	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860183001573	GS1

Premarket Submissions

Submission Number	Supplement Number
K250392	000