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.

Device Description

The Zap-X Radiosurgery System ("Zap-X System") is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. A gantry-mounted linear accelerator provides the Zap-X System with a source of therapeutic radiation and a kV imaging system is used to accurately locate the treatment target. At the start of treatment, X-ray images of patient skeletal anatomy serve to align the treatment target with respect to the system isocenter. During radiosurgical treatment, the kV imaging system of the Zap-X System tracks patient movement and adjusts the table precisely to compensate for such movement.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Zap-X Radiosurgery System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study or a study directly assessing performance against quantitative criteria (e.g., accuracy metrics for an AI algorithm).

The nature of this document (a 510(k) for a radiation therapy system) means it presents a technical and safety comparison to existing devices, not a study evaluating AI performance against predefined acceptance criteria for a diagnostic/AI-driven device. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or measurable from this document.

Here's an analysis of what can be extracted and what cannot, based on the provided text:

Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" in the format typically seen for AI/diagnostic devices (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, it focuses on demonstrating that the Zap-X Radiosurgery System is as safe and effective as the predicate device(s) and performs as intended through non-clinical testing. The "performance" discussed relates to the engineering and functional performance of the radiotherapy system itself.

Acceptance Criteria (Inferred from 510(k) process for this device type)	Reported Device Performance (Summary from text)
Safety and Effectiveness Equivalence to Predicate Device: The device should not raise new questions of safety or effectiveness compared to legally marketed predicate devices.	"The collective results confirm that the Zap-X Radiosurgery System is safe and effective, meets its specifications, exhibits the required mechanical and functional characteristics for its intended use and demonstrate that the device is safe, effective and performs as safely and effectively as the legally marketed predicate device."
Meeting Established Specifications: The device's design, manufacturing, and operational processes should meet predefined technical specifications.	"The collective results of the nonclinical testing demonstrate that the design, the manufacturing and commissioning processes, safety controls, treatment planning and treatment delivery of the Zap-X Radiosurgery System meet the established specifications necessary for consistent performance during its intended use."
Nonclinical Performance (Bench Testing): Performance verified through various bench tests.	Bench Testing Included:- Electrical safety and electromagnetic compatibility testing- Software verification and validation testing (System and subsystem verification, system validation of commissioning, treatment planning, and treatment delivery)- Usability testing- Standards conformance testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1, IEC 60825-1, IEC 61217, IEC 62083)
Radiation Leakage/Protection: The system must protect operators and the general public from radiation.	"The Zap-X System was demonstrated to meet the requirements for radiation leakage and provide protection from radiation to the operator and general public similar to that of CyberKnife within a radiation shielded vault."
Technological Characteristics Comparability: Key technical features should be comparable to predicate/reference devices.	Detailed comparison table provided for: Regulation Number, Classification Product Code, Indications for Use, Accelerator (treatment beam), Dose rate, Depth of Dose Maximum, Treatment Beam, Moveable Treatment Beam, Patient Table/Couch, Shielding for ionizing radiation, Real-Time Dosimetry, Safety subsystem, System console/user interface software, Treatment target tracking software, Treatment planning software, Treatment delivery software.

1. Sample sizes used for the test set and the data provenance:

Sample Size: Not applicable. This document describes non-clinical bench testing, software V&V, and physical device performance verification, not an AI model trained or tested on a dataset of patient cases. There is no "test set" of patient data in the context of an AI algorithm described here.
Data Provenance: Not applicable. The "data" comes from engineering tests, software logs, and measurements on the physical device, not patient data from specific countries or types of studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This process does not involve establishing ground truth from experts on a patient image or clinical dataset. The "ground truth" for this device relates to engineering specifications, safety standards, and functional performance, which are verified through standard testing procedures by qualified engineers and testers.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable: No expert adjudication of clinical data or images is involved as this is a physical radiation therapy system, not an AI diagnostic device.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improved with AI vs without AI assistance:

Not Applicable: This is not an AI-assisted diagnostic device; it is a physical radiosurgery system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: No AI algorithm in the diagnostic sense is described. The "performance" is of the complete physical system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable in the traditional sense for AI/diagnostic devices: The "ground truth" here is based on engineering specifications, international and national standards (e.g., IEC standards), established physics principles of radiation therapy, and the performance characteristics of predicate devices. Verification ensures the device meets these pre-defined, measurable engineering and safety parameters.

7. The sample size for the training set:

Not Applicable: This device is a physical system with integrated software for control and planning. It is not an AI system trained on a "training set" of patient data like a typical deep learning algorithm. Software verification and validation (V&V) is performed, which involves testing against requirements, but this is distinct from training an AI model.

8. How the ground truth for the training set was established:

Not Applicable: As there's no "training set" of patient data in the AI sense, there's no ground truth establishment for it.

Summary of Document's Purpose:

This Section 510(k) submission for the Zap-X Radiosurgery System demonstrates substantial equivalence to existing predicate devices (CyberKnife M6 Systems and Leksell Gamma Knife Icon). The "study" proving its capabilities is primarily a comprehensive suite of nonclinical bench testing, software verification and validation, usability testing, and standards conformance testing. The acceptance criteria are implicitly that the device performs as intended, meets its design specifications, and is as safe and effective as the legally marketed predicate devices without raising new questions concerning safety or effectiveness. No clinical trials or AI performance evaluations with patient data are discussed or required for this type of submission for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21, 2017

Zap Surgical Systems % Ms. Darlene Crockett-Billig. Regulatory Consultant Experien Group, LLC 224 Airport Parkway, Suite 250 SAN JOSE CA 95110

Re: K171804

Trade/Device Name: Zap-X Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 15, 2017 Received: June 19, 2017

Dear Ms. Crockett-Billig:

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 (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. 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171804

Device Name Zap-X Radiosurgery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 201 Subpart D)	Own-Use The County Use (21 CFR 201 Subpart C)
☑	☐

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Notification K__171804

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Zap Surgical Systems, Inc. 590 Taylor Way, Suite A San Carlos, CA 94070 USA Phone: (650) 796-5302 FAX: (650) 832-1038

Contact Person:

Darlene Crockett-Billig Co-Founder and President Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: (408) 400-0856 FAX: (408) 400-0865

Date Prepared: June 15, 2017

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Zap-X™ Radiosurgery System

Generic/Common Name:

Medical charged-particle radiation therapy system

Regulation Number/Classification:

21 CFR 892.5050, Class II

Classification Product Code:

IYE

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PREDICATE DEVICE(S) [807.92(a)(3)]

Zap Surgical Systems, Inc. asserts that the Zap-X Radiosurgery System ("Zap-X System") is substantially equivalent to the predicate device. Accuray CyberKnife M6 Systems, cleared under 510(k) K150873. The Zap-X System and the predicate device are medical charged-particle radiation therapy systems, falling within 21 CFR 892.5050, Product Code IYE. The proposed Zap-X Radiosurgery System is comparable to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics, and safety characteristics. The Zap-X System is also appropriately comparable to another device (i.e., reference device), the Leksell Gamma Knife Icon (K151561). The Gamma Knife Icon is classified as a radionuclide radiation therapy system per 21 CFR 892.5750, Product Code IWB. This reference device is included as it is similar to the Zap-X System with respect to treatment energy, indications for use and other features.

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

The Zap-X Radiosurgery System is intended to provide treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

With regard to technological characteristics, the Zap-X Radiosurgery System, predicate device and reference device all have similar features and components. The Zap-X System and the CyberKnife utilize a Linac system to generate the treatment beam. Because the CyberKnife, a whole-body radiosurgery system, operates at a somewhat higher energy compared to the Zap-X System (6MV vs. 3MV. respectively), the Leksell Gamma Knife Icon (K151561) device, manufactured by Elekta Instruments AB, has been included as a reference device. Specifically, the Gamma Knife Icon, the indications for which include the treatment of head structures, operates at an energy of 1.17MV and 1.33MV by virtue of its 60 Cobalt irradiation sources. The energy of these photon beams is quite comparable to the average 1MV photons produced by the Zap-X System 3MV Linac.

The proposed device, as well as the predicate and reference devices all use a collimator to control the treatment beam size. The treatment beam sizes offered with the Zap-X System are within the ranges offered by the CyberKnife, as well as the Gamma Knife reference device. Moreover, all three systems deliver treatment beam from a variety of

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510(k) SUMMARY

directions. In addition, all three systems have a patient table to support and position the patient during treatment. The proposed device, predicate device and reference device all have an imaging system to accurately deliver radiation to the treatment target. All systems have control consoles and interface software to control and monitor the systems for treatment planning and treatment delivery. All systems include capabilities for patient tracking. The Zap-X System, like the CyberKnife, uses patient skeletal anatomy to align the treatment target with respect to the system isocenter. As with the CyberKnife, the Zap-X System uses the kV imaging system to track patient movement and adjust the table precisely to compensate for such movement during treatment. The Zap-X System, like the predicate and references devices, was extensively tested for electrical safety and electromagnetic compatibility per the relevant standards for medical electrical equipment, electron accelerators and radiotherapy equipment.

The primary difference in technological features between the predicate CyberKnife and the Zap-X System is that the latter is more compact and self-shielded, enabling it to be installed and used in a standard healthcare facility without a specialized shielded vault. The Zap-X System is comparable to the Gamma Knife Icon reference device with respect to design in that both systems are intended to treat lesions of the head. Although the Gamma Knife Icon does include some self-shielding that limits radiation exposure outside the treatment device, a specialized treatment vault is still required to protect both system operators and general public. Finally, the Zap-X System was demonstrated to meet the requirements for radiation leakage and provide protection from radiation to the operator and general public similar to that of CyberKnife within a radiation shielded vault.

SUBSTANTIAL EQUIVALENCE

With regard to a primary predicate device, the Zap-X System is most like the CyberKnife M6 System (K150873) manufactured by Accuray. Both devices share the same general intended use, i.e., the planning and performance of image guided stereotactic radiosurgery and precision radiotherapy. In addition, the proposed brain, head and neck targets to be treated by the Zap-X System are inclusive within the CyberKnife's indications for use, i.e., "for treatment of lesions, tumors and conditions anywhere in the body". Furthermore, the CyberKnife and Zap-X System have comparable major system components. A minor difference in the energy of the treatment beam (6MV vs. 3MV) does not raise any new issues in terms of either the safety or effectiveness of treatment.

The Zap-X System is also appropriately comparable to another device (i.e., reference device), the Leksell Gamma Knife Icon (K151561) manufactured by Elekta Instruments AB. Notably, the intended use of the Gamma Knife for "stereotactic irradiation of structures in the head" closely matches that being proposed for the Zap-X System. Moreover, a heavily shielded design intended to minimize the extent of ionizing radiation leakage, albeit to differing extents, results in both the Gamma Knife and Zap-X System sharing a rather similar shape. Finally, the energy of the ionizing radiation beams generated by the Gamma Knife's radionuclide Cobalt is quite similar to the average energy produced by the Zap-X System.

Detailed comparisons of the proposed Zap-X Radiosurgery System to the CyberKnife predicate device and Gamma Knife Icon reference device are provided in the following table.

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Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceCyberKnife M6Systems(K150873)	Reference DeviceGamma KnifeIcon(K151561)	Analysis ofDifferences
RegulationNumber	21 CFR 892.5050Medical charged-particle radiationtherapy system	21 CFR 892.5050Medical charged-particle radiationtherapy system	21 CFR 892.5750Radionuclideradiation therapysystem	Broadly all threedevices fallwithin thegeneral categoryof radiotherapysystems.
ClassificationProduct Code	IYE	IYE	IWB	--
Indications forUse	The Zap-XRadiosurgerySystem isintended toprovide treatmentplanning andimage-guidedstereotacticradiosurgery andprecisionradiotherapy fortumors, lesionsand conditions inthe brain, headand neck whenradiationtreatment isindicated.	The CyberKnifeM6 Systems areindicated fortreatment planningand image guidedstereotacticradiosurgery andprecisionradiotherapy forlesions, tumorsand conditionsanywhere in thebody whenradiation treatmentis indicated.	Leksell GammaKnife® Icon™ is ateletherapy deviceintended forstereotacticirradiation of headstructures rangingfrom very smalltarget sizes of afew millimeters toseveralcentimeters, e.g.metastatic tumors,arteriovenousmalformations,trigeminalneuralgia,medicallyrefractoryessential tremor,meningiomas,vestibularschwannomas,post-surgicalpituitaryadenomas andrecurrentglioblastomas.	Zap-X SystemIndications fallswithin broadindication ofCyberKnife andhas sameintended use asthe GammaKnife Icon fortreatment oflesions in thehead.
Accelerator(treatmentbeam)	3MV nominalphoton beamenergy	6 MV nominalphoton beamenergy	Not Applicable.Irradiation Sourceis 60Cobalt withemission at 1.17and 1.33MV	Energy level ofZap-X fallswithin range ofCyberKnife andGamma KnifeIcon.
Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceCyberKnife M6Systems(K150873)	Reference DeviceGamma KnifeIcon(K151561)	Analysis ofDifferences
Dose rate (inMU/min)	1500±10%MU/min at450 mm	1000±10%MU/min at800 mm	300 cGy/min(in comparingisotopes toLinacs:1 cGy~1MU)	Zap-X Systemdose rate issimilar to theCyberKnife.
Depth of DoseMaximum(Dmax)	7 ±1 mm	15±2 mm	~5 mm	Depth atmaximum dosefor Zap-XSystem is verycomparable toGamma KnifeIcon which isappropriate,given its similarintended use.
TreatmentBeam	8 available beamsizes: diametersof 4.0, 5.0, 7.5,10.0, 12.5, 15.0,20.0 and 25.0 mmat the Source toAxis distance of450 mm.	5, 7.5, 10, 12.5,15, 20, 25, 30, 35,40, 50 and 60 mmdiameter fieldsizes at 800 mmSAD (with IrisApertureCollimator)	System uses 3different sets offixed collimatorapertures (4 mm,8mm and 16 mm)	Zap-X Systemtreatment beamsizes fall withinavailable sizes ofthe predicate andreferencedevices.
MoveableTreatmentBeam	Yes - Two degreeof freedom gantry	Yes - 6 degree offreedom roboticarm	No - 192 60Cosource arranged in'hemisphere' totreat intracraniallesions	All systemsdeliver treatmentbeam from avariety ofdirections.
PatientTable/Couch	Yes	Yes	Yes	All systems havea patient table orcouch to supportpatient duringtreatment.
Shielding forionizingradiation	Self-shielded	Treatment Vault	Partial Self-shielding andTreatment Vault	All three systemsprotect theoperator and thegeneral publicfrom theradiation fromthe machine.
Real-TimeDosimetry	Yes	Yes	No	Like thepredicate, theZap-X Systemincludes real-time dosimetry.
Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceCyberKnife M6Systems(K150873)	Reference DeviceGamma KnifeIcon(K151561)	Analysis ofDifferences
Safetysubsystem	Yes	Yes	Yes	All systemsprovide safetycontrolsubsystems.
System console(operatingpanel) and userinterfacesoftware	Yes	Yes	Yes	All systemsprovide controlconsoles.
Treatmenttargettrackingsoftware	Yes	Yes	Yes	All systemsallow for patienttracking duringtherapy.
Treatmentplanningsoftware	Yes	Yes	Yes	All systemsinclude treatmentplanningsoftware.
Treatmentdeliverysoftware	Yes	Yes	Yes	All systemsprovidetreatmentdeliverysoftware.

Substantial Equivalence Table

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510(k) SUMMARY

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510(k) SUMMARY

PERFORMANCE DATA [807.92(b)]

Zap Surgical Systems has performed bench testing to ensure that the Zap-X Radiosurgery System performs as intended.

[807.92(b)(1)| Nonclinical Testing Summary:

The nonclinical, bench testing included:

Electrical safety and electromagnetic compatibility testing
Software verification and validation testing ●
o System and subsystem verification testing
System validation testing of system commissioning, treatment planning and treatment delivery
. Usability testing
Standards conformance testing related to radiotherapy systems and radiographic o equipment

The standards used in the development and testing of the Zap-X System include the following:

IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for . basic safety and essential performance

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. IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-1:2014, Medical electrical equipment - Part 2-1: Requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60825-1, 2014: Safety of laser products Part 1: Equipment classification and requirements
IEC 61217, 2011-12: Radiotherapy equipment - Coordinates, movements and scales
IEC 62083, 2009-09: Medical electrical equipment Requirements for the safety of ● radiotherapy treatment planning systems

The collective results of the nonclinical testing demonstrate that the design, the manufacturing and commissioning processes, safety controls, treatment planning and treatment delivery of the Zap-X Radiosurgery System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Zap-X Radiosurgery System does not raise different questions of safety or effectiveness for image guided stereotactic radiosurgery and precision radiotherapy when compared to the predicate devices.

[807.92(b)(2)] Clinical Testing Summary:

This section is not applicable. No clinical testing was performed to support this premarket notification.

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical safety and performance testing has been performed on the Zap-X Radiosurgery System to evaluate the overall performance of the device. The collective results confirm that the Zap-X Radiosurgery System is safe and effective, meets its specifications, exhibits the required mechanical and functional characteristics for its intended use and demonstrate that the device is safe, effective and performs as safely and effectively as the legally marketed predicate device.

The proposed Zap-X Radiosurgery System was compared to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. Based on this comparison, there were only minor differences in the technological characteristics between the devices which do not raise any different questions of safety or effectiveness. In addition, the Zap-X System is similar to the reference device with regard to treatment energy, indications for use and other system features. By virtue of the above analysis, the Zap-X System is considered to be substantially equivalent to the primary predicate device.

SUMMARY

The Zap-X Radiosurgery System is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.