(264 days)
The ZAP-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.
The self-shielded ZAP-X® Radiosurgery System is a computer-controlled system for planning and delivering non-invasive stereotactic radiosurgery for tumors, lesions and conditions in the brain, head, and neck when radiation treatment is indicated. The system is self-shielded for ionizing radiation, allowing it to be installed in a non-bunker environment. A linear accelerator mounted on a dual-gantry provides a therapeutic radiation source, and a kV imaging system is used to locate and track the treatment target throughout the treatment.
N/A
FDA 510(k) Clearance Letter - ZAP-X Radiosurgery System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
November 3, 2025
Zap Surgical Systems, Inc.
Junyi Wang
Director, Regulatory Affairs
590 Taylor Way
San Carlos, California 94070
Re: K250392
Trade/Device Name: ZAP-X Radiosurgery System (ZAP-X)
Regulation Number: 21 CFR 892.5050
Regulation Name: Medical Charged-Particle Radiation Therapy System
Regulatory Class: Class II
Product Code: IYE, MUJ
Dated: February 11, 2025
Received: February 12, 2025
Dear Junyi Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250392 - Junyi Wang Page 2
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
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K250392 - Junyi Wang Page 3
requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lora D. Weidner
Assistant Director
Radiation Therapy Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250392
Device Name: ZAP-X Radiosurgery System (ZAP-X)
Indications for Use (Describe)
The ZAP-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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ZAP-X Radiosurgery System Traditional 510(k) Notification
510(k) #: K250392
510(k) Summary
Nov. 3, 2025
APPLICANT: ZAP Surgical Systems, Inc.
590 Taylor Way
San Carlos, CA 94070
United States
APPLICANT CONTACT: Junyi Wang
Director, Regulatory Affairs
junyi@zapsurgical.com
+1 (678) 580-8188
SUBJECT DEVICE
| Trade Name | ZAP-X Radiosurgery System |
|---|---|
| Model | ZAP-X |
| Common Name | Medical charged-particle radiation therapy system |
| Regulation Number | 21 CFR 892.5050 |
| Product Code | IYE, MUJ |
| Classification Name | Accelerator, Linear, Medical |
| Classification | Class II |
PREDICATE DEVICES AND REFERENCE DEVICE
| Predicate Device | ZAP-X Radiosurgery System (K211663) |
|---|---|
| Reference Device | Akesis Galaxy (K190844) |
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DEVICE DESCRIPTION SUMMARY
The self-shielded ZAP-X® Radiosurgery System is a computer-controlled system for planning and delivering non-invasive stereotactic radiosurgery for tumors, lesions and conditions in the brain, head, and neck when radiation treatment is indicated. The system is self-shielded for ionizing radiation, allowing it to be installed in a non-bunker environment. A linear accelerator mounted on a dual-gantry provides a therapeutic radiation source, and a kV imaging system is used to locate and track the treatment target throughout the treatment.
Key Subsystems and Accessories of the ZAP-X Radiosurgery System
-
ZAP-Axon® Treatment Planning System: 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.
-
Treatment Delivery System: the dedicated software application that enables loading and delivering of treatment plans on the ZAP-X Radiosurgery System. It includes the functionalities for quality assurance, loading and reviewing plans, performing automatic patient setup, reviewing image guidance results, delivering the planned dose, and producing delivery reports. It also manages the interlocks of the system.
-
Linear Accelerator: The ZAP-X utilizes a linear accelerator to produce therapeutic x-rays.
-
Circular Beam Collimation: The ZAP-X provides circular fields of various sizes up to 25 mm to enable the dose to be conformed to the target volume.
-
Dual Gantry: The ZAP-X utilizes a unique, dual gantry system to enable the radiation to be delivered from multiple, non-coplanar points. The structure of the gantries also provides radiation shielding, generally negating the need for any additional shielding when installing the system.
-
KV Imaging: The ZAP-X includes a kilovoltage x-ray imaging system that is used for image-based patient alignment and tracking.
-
DoseGuard® Patient Safety System: 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.
-
Patient Table: The ZAP-X utilizes a patient table to position the patient for treatment. The patient is immobilized with a thermoplastic mask or the PinZ Patient Immobilizer.
-
PinZ® Patient Immobilizer: an optional accessory designed for rigid, non-invasive head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
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INDICATIONS FOR USE
The ZAP-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device has been developed by modifying the predicate device ZAP-X Radiosurgery System (K211663). Modifications to the subject device do not impact safety or effectiveness.
The modifications being addressed in this 510(k):
-
Treatment Planning System
- Introduced the trade name ZAP-Axon Treatment Planning System with a new graphical user interface.
- Updated image fusion user interface, added support for additional views and automated fusion of multiple series.
- Expanded the number and type of supported contours.
- Refactored and optimized path planning algorithms, and updated collision models to reflect the conformal table insert.
- Optimized processing speed by general algorithm refactoring, including dose calculation and dose optimization.
- Enabled treatment plan comparison.
- Added support for custom CT density tables.
-
Treatment Delivery System
- Introduced Gyroscopic Correction, an optional feature that uses image guidance results to update the gantry position to correct for patient rotations.
- Reduced processing time and increased robustness of patient tracking and alignment (recall number: Z-1742-2022).
- Implemented minor updates and corrections to collision detection and detour logic (recall number: Z-2639-2025).
-
Cybersecurity
- Implemented cybersecurity enhancements, including OS and network security updates and executable/configuration checks.
-
Hardware
- Replaced the flat table insert with the conformal table insert.
- Increased the maximum table load from 135 kg to 210 kg.
- Replaced table railings with brackets for securing straps.
- Added an emergency shell release that enables opening the shell without electrical power.
- Increased maximum nominal dose rate to 1800 MU/min.
- Added supplementary shielding to small areas.
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-
Accessories
- Updated the DoseGuard housing and mounting and assigned a new trade name.
- Introduced the PinZ Patient Immobilizer as an optional accessory.
-
Labeling
- Revised labeling to reflect the design changes listed above.
The subject and predicate devices have the same indications for use, operating principles, and similar technological characteristics. The changes do not raise different questions of safety or effectiveness. A summary of the technological characteristics of the subject device compared to the predicate device is provided below, and a second table is provided for the optional accessory compared to the reference device (K190844):
| Subject | Predicate Device ZAP-X Radiosurgery System (K211663) | Subject Device ZAP-X Radiosurgery System (K250392) |
|---|---|---|
| Product Code | IYE | IYE, MUJ |
| Regulation Number | 21 CFR 892.5050 | Same |
| Rx/OTC | Rx | Same |
| Indications for use | The ZAP-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated. | Same |
| Treatment Site | Brain, head, and neck | Same |
| Target Patient Population | The system is intended for use for treatments in the head and neck on patients that are between the size of a 5th percentile female to a 95th percentile male. | Same |
| Number of Treatment sessions | Single fraction or a short course of hypofractionation (2-5 sessions) | Same |
| Moveable Treatment Beam | Yes – Two degree of freedom gantry | Same |
| Shielding for Ionizing Radiation | Self-shielding | Similar - Added supplementary shielding in small areas, overall performance remains equivalent. |
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| Subject | Predicate Device ZAP-X Radiosurgery System (K211663) | Subject Device ZAP-X Radiosurgery System (K250392) |
|---|---|---|
| Treatment Beam Energy | 3MV nominal photon beam energy | Same |
| Real-Time Dosimetry (Ion Chamber based dose monitoring systems) | Yes | Same |
| Treatment Planning Software | Software subsystem | Similar - New graphical user interface (GUI), New trade name: "ZAP-Axon® Treatment Planning System", Updated image fusion user interface, added support for additional views and automated fusion of multiple series. Expanded the number and type of supported contours. Refactored and optimized path planning algorithms, and updated collision models to reflect the conformal table insert. Optimized processing speed by general algorithm refactoring, including dose calculation and dose optimization. Enabled treatment plan comparison. Added support for custom CT density tables. |
| Treatment Delivery Software | Integrated | Similar - New Gyroscopic Correction feature. Reduced processing time and increased robustness of patient tracking and alignment. Implemented minor updates and corrections to collision detection and detour logic. |
| Accessory | MV Imager (Disposable Dosimeter) | Similar. DoseGuard® (new appearance and trade name for MV Imager) with manufacturability; no change to intended use or functionality. |
| Optional Accessory | N/A | PinZ® Patient Immobilizer (new optional accessory) |
Performance Specification
| Predicate Device ZAP-X Radiosurgery System (K211663) | Subject Device ZAP-X Radiosurgery System (K250392) | |
|---|---|---|
| Treatment Beam Energy | 3MV nominal photon beam energy | Same |
| Percentage Depth Dose: | PDD (10cm) = 40% ± 2% | Same |
| Dose rate (in MU/min) | 1500±10% MU/min at 450mm SAD | Maximum nominal dose rate 1800 ±10% MU/min at 450mm SAD. |
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| Subject | Predicate Device ZAP-X Radiosurgery System (K211663) | Subject Device ZAP-X Radiosurgery System (K250392) |
|---|---|---|
| Penumbra at depth of maximum dose | 25 mm field size: 2.25 mm | 25 mm field size: 2.5 mm |
| Overall System Patient Positioning Accuracy | within ± 1mm | Same |
| Treatment Beam | Available circular beam sizes: diameters of 4.0 mm, 5.0 mm, 7.5 mm, 10.0 mm, 12.5 mm, 15.0 mm, 20.0 mm, and 25.0 mm at isocenter | Same |
| Predetermined Change Control Plan (PCCP) | N/A | PCCP included in the submission to add 3mm beam size at isocenter. |
| Subject | Reference Device Akesis Galaxy (K190844) | Optional Accessory PinZ Patient Immobilizer |
|---|---|---|
| Indications for Use | The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures. | This optional accessory is intended to be used with the ZAP-X Radiosurgery System, to provide rigid immobilization of the head during stereotactic radiosurgery and precision radiotherapy when indicated by the physician. |
| Head Frame Material | Anodized aluminum | Similar |
| Cranial Pins Material | Ti 6Al-4V | Similar |
| Head Frame Patient Fixation | Four Pins | Similar |
| Sterilization | Cleaning and Autoclave Sterilization | Similar |
NON-CLINICAL AND CLINICAL TESTS SUMMARY
The following performance data were provided in support of the substantial equivalence determination.
The subject device (ZAP-X Radiosurgery System) has undergone formal design verification and design validation testing including electrical safety, electromagnetic compatibility, radiation safety, software verification and validation, system verification and validation, biocompatibility, usability and cybersecurity
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testing. New functionality, such as gyroscopic correction, was verified and validated against pre-defined acceptance criteria established to ensure safe and effective performance. Improvements to existing functionalities, such as image fusion, dose calculation, dose optimization, image guidance and collision detection, were tested against acceptance criteria that were based upon the criteria for the predicate device. This testing was enhanced and expanded where appropriate. In all respects, test results indicated that the defined acceptance criteria were met and the system, its components and accessories meet their specifications and are appropriate for their intended use.
The new optional accessory to ZAP-X Radiosurgery System (PinZ Patient Immobilizer), in addition to design verification and validation, has also undergone cleaning and sterilization validation, biocompatibility testing, and usability testing.
A formative clinical study for the optional accessory PinZ Patient Immobilizer was conducted early in development to identify preliminary use-related risks, evaluate and refine critical tasks, and inform design improvements. It was followed by a summative usability validation study for the ZAP-X Radiosurgery System and PinZ Patient Immobilizer, conducted in accordance with IEC 62366 and FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices to verify that the device performs as intended for the intended users, uses, and use environments.
Use of Consensus Standards
The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and effectiveness as compared to the predicate.
| Standard | Name |
|---|---|
| IEC 60601-1:2020 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2:2020 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests |
| IEC 60601-1-3 2021 | Medical electrical equipment –Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60601-1-6:2020 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
| IEC 62366-1:2020 | Medical devices – Application of usability engineering to medical devices |
| IEC 60601-2-1:2020 | Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| IEC 60601-2-68:2014 | Medical electrical equipment – Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| IEC/TS 60601-4-2:2024 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| IEC 60825-1:2014 | Safety of laser products – Part 1: Equipment classification and requirements |
| IEC 60976:2007 | Medical electrical equipment – Medical electron accelerators – Functional performance |
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| Standard | Name |
|---|---|
| characteristics | |
| IEC 61217:2011 | Radiotherapy equipment – Coordinates, movements and scales |
| IEC 62083:2009 | Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems |
| IEC 62304:2006/AMD 1:2015 | Medical device software – Software life-cycle processes |
| IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle |
| ISO 14971:2019 | Medical devices- Application of risk management to medical devices |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. |
| ISO 10993-5:2009 | Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
PREDETERMINED CHANGE CONTROL PLAN (PCCP)
The predetermined change control plan (PCCP) for the device specifies anticipated modifications to the ZAP-X System software and hardware to support an additional circular beam size with 3.0 mm diameter.
The PCCP provides a description of the device's planned modification, the modification protocol to test, verify, and validate the modification; and an impact assessment and implementation plan which together will ensure the modified device is as safe and effective as the predicate.
A summary of the modifications, testing methods, performance requirements, validation activities, and user communication is provided in the table below:
| Planned Modification | Testing Methods, Validation Activities and Performance Requirements | Communication to Users |
|---|---|---|
| One additional circular beam size with a 3.0 mm diameter. This change will include changes to hardware (a new collimator wheel) and software (TPS to enable commissioning and planning for the new field size and TDS to select, display and deliver the new field size). | Testing of the ZAP-Axon Treatment Planning System will include verifying the completeness of beam commissioning data for the selected collimator configuration prior to planning, and the usage of corresponding beam data for dose calculation when 3.0 mm beam size is selected. Testing of the Treatment Delivery System will include verifying the | Existing users will be notified that an upgrade is available and will require both hardware and software updates to their system. If requested, a user's system hardware and software will be upgraded and they will be provided with updated user manuals and receive training regarding commissioning and using the new 3.0 mm beam. |
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| Planned Modification | Testing Methods, Validation Activities and Performance Requirements | Communication to Users |
|---|---|---|
| collimator calibration procedure, the selection of 3.0 mm beam size when specified by the treatment plan, and the display of 3.0 mm beam size (if used) in the delivery report. Validation testing will be carried out to validate that the new field size provides clinical benefit and that planned and delivered dose volumes agree. These tests are a part of ZAP's established protocol for tests related to collimator field sizes. Additional testing will include adherence to applicable clauses of IEC 60976, IEC 62083, IEC 62304 and IEC 60601-2-1. | For new users, Labeling (including ZAP-Axon manual, treatment delivery manual, beam data manual) and marketing materials will be provided in accordance with the authorized PCCP. All users will receive training for the trade-off of using a 3.0 mm beam size and the process of properly commission the system to use the 3.0mm beam. |
CONCLUSION
The principle of operation of the subject device is the same as that of the existing predicate device. Verification and validation testing demonstrated that the subject device is as safe and effective as the predicate. ZAP therefore concludes that the subject device ZAP-X Radiosurgery System is substantially equivalent to its cleared predicate device.
N/A