The ImagingRing System (IRS) is an X-rav device consisting of (1) imaging components, supports and (2) patient support structure (couch top), designed to support patient localization in the Couch Coordinate System (CCS) and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician.

IRS facilitates patient localization by means of imaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.

IRS provides 2D planar imaging (including streaming and recording sequences of 2D frames for motion and 3D volumetric imaging before, during and after irradiation, and is intended to support pationing, monitoring and management of internal target motion, and decision making as a function, size, shape and displacement resulting from patient set-up deviation. organ deformation and anatomical movement.

With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, IRS is intended to be:

· embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) in order to receive commands and data from and provide information to (e.g., receiving command from RTCS to start an image acquisition and providing image data to RTCS for the purpose to calculate and execute the patient (re)-positioning vector externally in the third party system)

· interfaced with a Patient Positioning Systems (PPS), like - but not limited to - a robotic multi-axis system, to allow the calculated (re)-positioning vector to be applied with respect to Coordinate Systems the treatment delivery unit relates to.

Device Description

The medPhoton IRS is a standalone imaging system designed to obtain TwoDimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment.

The IRS consists of

· hardware called ImagingRing (IR) consisting of couch top, ring, detector, X-ray source, generator, etc .;
· software called ImagingRing Software Suite (ImRiSS), to orchestrate image acquisition and data processing:
. programmable logic controller (PLC) components and related software (e.g., ImagingRing Control System - IRCS), to execute and control image acquisition.

The system is designed in a way such that it provides the following key features:

1. During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
1. The X-ray source and detector can move independently in order to enable nonisocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the axial Field Of View (FOV).
1. The combination of imaging arm and couch top is designed to be directly attached to a range of Patient Positioning Systems (PPS) including multi-axis robotic devices.

The imaging device is integrated with a couch top. The independently moveable components allow for acquisition of X-ray projective images. These provide the foundation for 2D planar imaging as well as acquisition and reconstruction of 3D ConeBeam Computed Tomography (CBCT) images around customizable centers of interest.

AI/ML Overview

The provided text describes the medPhoton ImagingRing System (IRS) and compares its characteristics to predicate devices (Elekta XVI R5.0 and Qfix kVue) to demonstrate substantial equivalence for FDA 510(k) clearance. However, the document does NOT contain details about a specific study proving the device meets acceptance criteria. Instead, it outlines performance characteristics and states that testing was performed to evaluate safety and performance requirements.

Therefore, the following information will be extracted from the comparison tables and accompanying text. Aspects not mentioned in the document will be explicitly stated as "Not mentioned in the provided text."

1. A table of acceptance criteria and the reported device performance

The document presents performance characteristics by comparing the ImagingRing System's specifications against those of predicate devices. The values for the predicate devices essentially serve as the "acceptance criteria" or benchmarks that the new device aims to match or exceed for substantial equivalence.

Characteristic	Acceptance Criteria (Predicate Device XVI R5.0)	Reported Device Performance (ImagingRing System)
Position Accuracy	±0.3°	±0.2°
2D low contrast visibility	≥12 disks visible	≥12 disks visible
2D spatial resolution	≥1.4 line/mm	≥1.6 line/mm
CBCT spatial resolution	≥7 lp/cm	≥10 lp/cm (up to 18)
CBCT low contrast resolution	< 1.5%	< 1.5%
CBCT uniformity	< 2%	< 2%
Transverse geometric accuracy	< 1 mm	< 1 mm
Leakage radiation (loading state)	< 1.0 mGy/h	0.1979 mGy/h
Leakage radiation (not loading)	< 20 mGy/h	0 mGy/h
X-ray beam must not be larger than boundaries by more than 3% of SID (image receptor plane)	Yes	Yes
Aluminum Equivalence Thickness (AET) @ 100kVp	Not specified (kVue context)	1.9 mm (compared to kVue)
Water Equivalence Thickness (WET) @ 6 MV	Not specified (kVue context)	≤16.5 mm (compared to kVue)
Meets deflection requirements of IEC 60976	< 5 mm (kVue)	< 1 mm effect in imaging volume accuracy (compared to kVue)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not mentioned in the provided text. The document refers to "module and integration verification as well as system level validation" but does not detail specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not mentioned in the provided text.

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

Not mentioned in the provided text.

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

Not mentioned in the provided text. This document describes an imaging hardware system, not an AI-assisted diagnostic tool for human readers.

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

The document does not describe a "standalone" algorithmic performance in the context of an AI device. It describes the ImagingRing System as a standalone imaging system (hardware and software) designed to acquire images and support patient localization. Its performance metrics (e.g., spatial resolution, low contrast visibility) characterize the system itself, not an algorithm's diagnostic capabilities.

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

Not explicitly mentioned for the reported performance metrics. However, typical "ground truth" for physical performance metrics like spatial resolution, low contrast visibility, and geometric accuracy usually involves physical phantoms (e.g., Catphan 503 mentioned as a phantom for predicate device data) and calibrated measurement systems.

8. The sample size for the training set

Not applicable. The document describes a medical imaging device, not a machine learning model that would typically have a "training set."

9. How the ground truth for the training set was established

Not applicable. The document describes a medical imaging device, not a machine learning model that would typically have a "training set."

Summary

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

medPhoton GmbH % Mr. Daniel Schaffarzick Official Correspondent Strubergasse 16 Salzburg, 5020 AUSTRIA

Re: K161400 Trade/Device Name: ImagingRing System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 4, 2016 Received: November 8, 2016

Dear Mr. Schaffarzick:

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Michael D'Hara

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) K161400

Device Name ImagingRing System

Indications for Use (Describe)

With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, IRS is intended to be:

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)
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medPhoton GmbH

Traditional 510(k) Submission

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Image /page/3/Picture/2 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'p' connected in a stylized, cursive font, with the 'p' resembling the Greek letter Phi (Φ). The letters are in blue. Below the symbol, the word "medPhoton" is written in a smaller, gray sans-serif font.

510(k) Summary

In accordance with the requirements of the Safe Medical Device Act, medPhoton GmbH herewith submits a 510(k) Summary.

This 510(k) summary for the ImagingRing System meets the requirements of 21 CFR 807.92.

Date Prepared:	November 04th, 2016
Submitter Information:	medPhoton GmbHStrubergasse 165020 SalzburgAustriaPhone: 0043 699 161 053 86Registration Number: not currently registeredOwner/Operator Number: -
Official Correspondent:	Mr. Daniel SchaffarzickmedPhoton GmbHStrubergasse 165020 SalzburgAustriaPhone: 0043 699 161 054 06
US Agent (Contact):	Dr. Christian KesbergÖsterr. AußenwirtschaftsCenter New York120 West 45th Street, 9th FloorNew York, NY 10036Phone: T +1 212 421 52 50E-mail: newyork@wko.at
Device(s) Identification:Device Trade Name:Device common name:Device Classification Name:Regulation Description:Product Code:Reference:Review Panel:Device Class:	ImagingRing SystemImagingRing SystemAccelarator, Linear, MedicalMedical charged-particle radiation therapy systemIYEper 21 CFR 892.5050RadiologyII

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 – 2/9

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Image /page/4/Picture/2 description: The image contains a logo for a company called "medPhoton". The logo features the company name in a simple, sans-serif font, with "med" in gray and "Photon" in a darker shade. Above the company name is a stylized graphic that appears to be a combination of a lowercase "m" and the Greek letter "Phi", both in a blue color. The "m" is drawn with a flowing, curved line, while the "Phi" symbol is more geometric.

Device Description:

The IRS consists of

· hardware called ImagingRing (IR) consisting of couch top, ring, detector, X-ray source, generator, etc .;
· software called ImagingRing Software Suite (ImRiSS), to orchestrate image acquisition and data processing:
. programmable logic controller (PLC) components and related software (e.g., ImagingRing Control System - IRCS), to execute and control image acquisition.

The system is designed in a way such that it provides the following key features:

1. During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
1. The X-ray source and detector can move independently in order to enable nonisocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the axial Field Of View (FOV).
1. The combination of imaging arm and couch top is designed to be directly attached to a range of Patient Positioning Systems (PPS) including multi-axis robotic devices.

Intended Use:

The ImagingRing System (IRS) is an X-ray device consisting of (1) imaging components, supports and software and (2) patient support structure (couch top), designed to support patient localization in the Couch Coordinate System (CCS) and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image quidance is determined by a licensed physician.

IRS provides 2D planar imaging (including streaming and recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, and is intended to support patient positioning, monitoring and management of internal target motion,

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 – 3/9
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Image /page/5/Picture/2 description: The image shows the logo for medPhoton. The logo features a stylized blue symbol resembling a lowercase 'm' connected to a Greek letter 'Phi'. Below the symbol, in gray text, is the word 'medPhoton'.

and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement.

With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, IRS is intended to be:

. embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) in order to receive commands and data from and provide information to (e.g., receiving command from RTCS to start an image acquisition and providing image data to RTCS for the purpose to calculate and execute the patient (re)positioning vector externally in the third party system)

interfaced with a Patient Positioning Systems (PPS), like - but not limited to - a robotic . multi-axis system, to allow the calculated (re)-positioning vector to be applied with respect to Coordinate Systems the treatment delivery unit relates to.

Predicate devices:

Primary Predicate

Device Trade Name:	XVI R5.0
Applicant:	Elekta Limited
510(k) No.:	K131965
2.
Device Trade Name:	kVue™ IGRT Couch top
Applicant:	Aquaplast/Qfix
510(k) No.:	K060671

The ImagingRing System is considered substantial equivalent to the Elekta XVI R5.0 (K131965) and the kVue™ IGRT Couch top (K060671).

1. Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the ImagingRing System and the predicate devices.
1. There is no significant difference in intended use or technology.

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 – 4/9
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Image /page/6/Picture/6 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'p' in a stylized, cursive font, with the 'p' resembling the Greek letter phi. Below the symbol is the word 'medPhoton' in a smaller, sans-serif font.

Summary of Technological Characteristics:

Characteristics	ImagingRing System	XVI R5.0
510(k)	-	K131965
Manufacturer	medPhoton GmbH	Elekta Limited.
Product code	IYE	IYE
Indications for use
Used with a charged particle or photonradiation therapy system	✓	✓
Verification of patient setup position	✓	✓
Image acquisition
X-ray imaging with digital flat panel detector	✓	✓
Stereoscopic acquisition	✓	✓
CBCT	✓	✓
Temperature	15°C to 30°C	10°C to 35°C
Humidity	30 to 65 %	30% to 70%
Atmospheric Pressure	80 kPa to 110 kPa	80 kPa to 106 kPa
Motorized movements laterally andlongitudinally	✓	✓
Touchguard prevents collision	✓	✓
source just delivers radiation when thesource arm is situated in a locked position	-	✓
Touchguard prevents collision	✓	✓
Movements are continuously variable	✓	✓
Beam rotates radially through 360° in thedirection of the isocenter	✓	✓
Speed	0 to 1 revolutions/min	0 to 1 revolutions/min
Position Accuracy	$\pm0.2°$	$\pm0.3°$
Inherent filtration	1.4	1.4
Added filtration	5.2	5.6
Total filtration at100 kV	6.6	7.0
Nominal voltage	230 V	400 V, 415 V, 440 V,or 480 V
Voltage variation	±10%	±10%
Phases	Single-phase and earth	Three-phase and earth
Frequency	50 - 60 Hz	48 Hz or 62 Hz, ±2%
Impedance	0.2 Ohms	0.348 ohms to 0.501 ohms
Fuse rating	32 A	63 A circuit recommended
confinement of extra focal radiation	extra focal radiation is not morethan 15 cm on each side of thelargest X-ray field	extra focal radiation is notmore than 15 cm on eachside of the largest X-ray field
beam limits	Independently moveable X andY jaws to shape the x-ray field ofirradiation	collimator cassettes that youcan manually change to setthe size of the X-ray beam
leakage radiation in the loading state	0.1979 mGy/h	< 1.0 mGy/h
leakage radiation when not in the loadingstate	0 mGy/h	< 20 mGy/h
Relation between the X-ray field and imagereceptor area	At the image receptor plane, theX-ray beam must not be largerthan the boundaries by more	At the image receptor plane, theX-ray beam must not belarger than the boundaries by

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 – 5/9
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Image /page/7/Picture/0 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'p' in lowercase, with the 'p' stylized to resemble the Greek letter phi (Φ). The letters are in a blue color. Below the letters, the word 'medPhoton' is written in a smaller, gray font.

	than 3% of the source-to-imagedistance along the two majoraxes	more than 3% of the source-to-image distance along thetwo major axes
Radiation warning lamp	✓	✓
80 kV	4.4 mm Al	6.1 mm Al
120 kV	6.3 mm Al	8.5 mm Al
Generator operating range	40 - 120 kVp	70 - 150 kVp1
Flat panel detector pixel size	400 μm	400 μm1
Flat panel matrix	1024 x 1024	1024 x 10241
2D low contrast visibility	≥12 disks visible	≥12 disks visible2
2D spatial resolution	≥1.6 line/mm	≥1.4 line/mm2
CBCT spatial resolution	≥10 lp/cm (up to 18)	≥7 lp/cm1
CBCT low contrast resolution	< 1.5%	< 1.5%2
CBCT uniformity	< 2%	< 2%2
Transverse geometric accuracy	< 1 mm	< 1mm1
FlexMap3	Yes	yes1
Presets and automatic setup	The ImagingRing Systemreceives information such aspatient and preset selection,from a third party system (e.g.the Radiotherapy ControlSystem of a treatment deliverydevice) for automatic set up ofimage acquisition parameters	SYNERGISTIQ4
2D planar imaging	✓	PlanarView5
Fluoroscopy mode	✓	MotionView6
	Recording of frame sequencesfor motion analysis (pulsedfluoroscopy-like acquisitionmode)
3D reconstruction	✓	VolumeView7
4D volume view	N/A	Symmetry8

1 Data from http://www.aapm.org/meetings/amos2/pdf/34-8077-2750-150.pdf

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 – 6/9
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2 http://chapter.aapm.org/seaapm/symposia/2015/Weatherford.pdf . Phantom used: Catphan 503.

3 The term FlexMap indicates a technique to compensate for the mounted components due to the difference in gravitational force along the rotation trajectory, leading to a difference between nominal and actual values as a function of the position in the trajectory.

4 In SYNERGISTIQ mode, the information from the patient management information system is used to automatically set up the image acquisition parameters, such as patient selection, reference data, and preset selection.

5 In the PlanarView mode. XVI uses presets to acquire one 2D planar image. The digital accelerator qantry does not move, a sequence of frames is acquired, and XVI does an average of these frames to create the image. The user can acquire images at applicable gantry angles in this mode.

6 In the MotionView mode, XVI uses presets to acquire a sequence of 2D planar images. This can be while the qantry rotates or with no gantry movement.

7 In the VolumeView mode, XVI acquires a sequence of 2D projection images while the digital accelerator gantry rotates. XVI uses the acquired images to reconstruct a 3D anatomical volume, which the operator can use for registration with imported CT reference data. This makes sure that the patient position is correct, and shows the target movement.

8 Symmetry is the acquisition, reconstruction, and registration of a 4D VolumeView. During a Symmetry VolumeView, XVI acquires the images and reconstructs them in relation to the breathing cycle over time. This lets the operator see the different phases of the breathing cycle for a patient.

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Image /page/8/Picture/0 description: The image shows the logo for medPhoton. The logo features a stylized lowercase 'm' connected to the Greek letter Phi (Φ) in blue. Below the symbol, the word "medPhoton" is written in gray, with "med" on the first line and "Photon" on the second line.

Intrafraction Imaging	The ImagingRing System,provided that no collision isdetected, is capable of acquiringimages while the treatmentbeam is ON.	Intrafraction imaging is anoption that lets you acquirekV images during an MVtreatment field delivery.
Segmental Technique	The ImagingRing System iscapable of interrupting imageacquisitions using the propercommand.	Lets you use theINTERRUPT button on theFKP to do a pause in aMotionView or VolumeViewacquisition.
Distributed Review	The ImagingRing Systemprovides a third party system(e.g. the Radiotherapy ControlSystem of a treatment deliverydevice) called requestor, withthe requested image dataset forimage review and furtherprocessing.	Distributed Review lets yousend data to the patientmanagement informationsystem in which you can dothe CBCT image review.
IEC 60601-1	✓	✓
IEC 60601-2-1	-	✓
IEC 60601-1-3	✓	✓
IEC 60601-2-44	✓	✓
IEC 60601-2-54	✓	✓
IEC 62304	✓	✓
IEC 62366	✓	✓
ISO 14971	✓	✓

Table 1: Comparison of technological characteristics of IRS and the predicate XVI R5.0

Characteristics	ImagingRing System	KVue
510(k)	-	K060671
Manufacturer	medPhoton GmbH	WFR/AQUAPLASTCORP/Qfix
Product code	IYE	JAI
Indications for use
Used with a charged particle or photonradiation therapy system	✓limited for use in particle therapyonly	✓
Patient setup position	✓	✓
Material
Advanced fiber composites that contain nometal parts in the treatment area.	✓	✓
Biocompatibility	✓	✓
Interface functionalities
Mountable on treatment tables using plateswith mechanical fixation.	✓	✓
Mechanical properties
Meets the deflection requirements of IEC60976 (<5 mm in the specified setup).	< 1 mm effect in imaging volumeaccuracyN/A	✓
Virtual Indexing	✓	✓

medPhoton GmbH	Traditional 510(k) Submission	Chapter 05 - 7/9
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Image /page/9/Picture/0 description: The image contains a logo for a company called medPhoton. The logo features the letters "m" and "Φ" (phi) in blue, with the word "medPhoton" written in gray below. The "m" and "Φ" are stylized and connected, creating a unique visual element for the brand.

Radiolucent: Aluminum EquivalenceThickness (AET): ~0.6 mm @ 100kVp;Water Equivalence Thickness (WET): 2-6mm @ 6 MV)	AET = 1.9 mmWET≤16.5 mm	✓
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Table 2: Comparison of technological characteristics of IRS and the predicate KVue

The ImagingRing System and the two predicate devices target the same population, i.e., patients undergoing radiotherapy workflows in a hospital environment. Therefore, they are subject to the same human factors and must provide the same compatibility with the environment and interaction with other devices such as - but not limited to positioning/immobilization devices, radiotherapy treatment delivery systems and patient positioning systems.

The ImagingRing System, like two predicate devices, can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies, prostate, and bone metastases.

The devices create the same functional outputs that support procedures during radiotherapy. This is reflected in the similarity of the indications for use of the devices. The differences in the environmental conditions for operation, gantry movement, electrical data, beam limiting devices, technical specifications, view mode options and attenuation properties do not have impact on safety and effectiveness. Therefore the IRS is considered substantial equivalent for the main functional characteristics and the indications for use.

The ImagingRing System is considered substantial equivalent to the Elekta XVI R5.0 (K131965) and the Qfix kVue (K060671). There is no significant difference in intended use or technology.

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Image /page/10/Picture/2 description: The image shows the logo for medPhoton. The logo features the letters 'm' and 'Phi' in a stylized, connected design, with the 'm' appearing in lowercase and the 'Phi' symbol in uppercase. The color of the letters is a bright, vibrant blue. Below the symbol is the word 'medPhoton' in a smaller, sans-serif font.

Summary of performance testing:

The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in chapter 9 (Declaration of Conformity and Summary Reports) which includes but not limited to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 62304, IEC 62366 and ISO 14971.

Testing was performed to evaluate the respective safety and performance requirements in the form of module and integration verification as well as system level validation. The results from verification and validation testing prove the conformance to applicable standards and demonstrate that safety & effectiveness have been achieved.

Animal Testing:

medPhoton GmbH did not perform any animal testing for the ImagingRing System.

Clinical Testing:

medPhoton GmbH did not perform any clinical testing for the ImagingRing System.

Conclusion: medPhoton GmbH believes that the ImagingRing System is substantially equivalent to the currently legally marketed devices. The ImagingRing System does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

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.