(202 days)
Not Found
No
The summary describes standard image acquisition and processing for radiation therapy guidance. There is no mention of AI/ML algorithms for image analysis, decision support, or other functions. The calculation of the re-positioning vector is explicitly stated as occurring externally in a third-party system.
No
The device is an X-ray imaging system used for image guidance in radiation therapy, assisting with patient localization and alignment, but it does not directly provide therapy.
No
The device is an imaging system designed for patient localization and image guidance in radiation therapy. Its purpose is to provide anatomical information for accurate patient positioning, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of both hardware (ImagingRing) and software (ImagingRing Software Suite and PLC software).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ImagingRing System (IRS) is an X-ray imaging device used for patient localization and image guidance during radiation therapy. It visualizes internal anatomy to help position the patient and monitor treatment.
- Lack of Specimen Analysis: The IRS does not analyze any specimens taken from the patient's body. It directly images the patient's internal structures using X-rays.
The device's intended use and description clearly indicate it's an imaging system for guiding external radiation treatment, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The ImagingRing System (IRS) is an X-ray 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 analysis) and 3D volumetric imaging before, during and after irradiation, and is intended to support patient positioning, monitoring and management of internal target motion, 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
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:
-
- During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
-
- 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).
-
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
all areas of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician, hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
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.
1
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
2
Indications for Use
510(k) Number (if known) K161400
Device Name ImagingRing System
Indications for Use (Describe)
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.
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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FORM FDA 3881 (8/14)
Page 1 of 1
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medPhoton GmbH
Traditional 510(k) Submission
Image /page/2/Picture/22 description: The image shows the text "Chapter 04 - 2/2". The text is written in a simple, sans-serif font and is left-aligned. The numbers indicate that this is chapter 4, and it is page 2 of 2.
3
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 GmbH |
| Strubergasse 16 | |
| 5020 Salzburg | |
| Austria | |
| Phone: 0043 699 161 053 86 | |
| Registration Number: not currently registered | |
| Owner/Operator Number: - | |
| Official Correspondent: | Mr. Daniel Schaffarzick |
| medPhoton GmbH | |
| Strubergasse 16 | |
| 5020 Salzburg | |
| Austria | |
| Phone: 0043 699 161 054 06 | |
| US Agent (Contact): | Dr. Christian Kesberg |
| Österr. AußenwirtschaftsCenter New York | |
| 120 West 45th Street, 9th Floor | |
| New York, NY 10036 | |
| Phone: T +1 212 421 52 50 | |
| E-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 System |
| ImagingRing System | |
| Accelarator, Linear, Medical | |
| Medical charged-particle radiation therapy system | |
| IYE | |
| per 21 CFR 892.5050 | |
| Radiology | |
| II |
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 2/9 |
|---|
4
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 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:
-
- During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
-
- 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).
-
- 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.
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 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 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 |
|---|---|---|
| ---------------- | ------------------------------- | ------------------ |
5
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).
-
- Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the ImagingRing System and the predicate devices.
-
- There is no significant difference in intended use or technology.
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 4/9 |
|---|---|---|
| ---------------- | ------------------------------- | ------------------ |
6
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 photon | ||
| radiation 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 and | ||
| longitudinally | ✓ | ✓ |
| Touchguard prevents collision | ✓ | ✓ |
| source just delivers radiation when the | ||
| source arm is situated in a locked position | - | ✓ |
| Touchguard prevents collision | ✓ | ✓ |
| Movements are continuously variable | ✓ | ✓ |
| Beam rotates radially through 360° in the | ||
| direction 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 at | ||
| 100 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 more | |
| than 15 cm on each side of the | ||
| largest X-ray field | extra focal radiation is not | |
| more than 15 cm on each | ||
| side of the largest X-ray field | ||
| beam limits | Independently moveable X and | |
| Y jaws to shape the x-ray field of | ||
| irradiation | collimator cassettes that you | |
| can manually change to set | ||
| the size of the X-ray beam | ||
| leakage radiation in the loading state | 0.1979 mGy/h | 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 |
|---|---|---|
| ---------------- | ------------------------------- | ------------------ |
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.
8
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 is
detected, is capable of acquiring
images while the treatment
beam is ON. | Intrafraction imaging is an
option that lets you acquire
kV images during an MV
treatment field delivery. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Segmental Technique | The ImagingRing System is
capable of interrupting image
acquisitions using the proper
command. | Lets you use the
INTERRUPT button on the
FKP to do a pause in a
MotionView or VolumeView
acquisition. |
| Distributed Review | The ImagingRing System
provides a third party system
(e.g. the Radiotherapy Control
System of a treatment delivery
device) called requestor, with
the requested image dataset for
image review and further
processing. | Distributed Review lets you
send data to the patient
management information
system in which you can do
the 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/AQUAPLAST |
| CORP/Qfix | ||
| Product code | IYE | JAI |
| Indications for use | ||
| Used with a charged particle or photon | ||
| radiation therapy system | ✓ | |
| limited for use in particle therapy | ||
| only | ✓ | |
| Patient setup position | ✓ | ✓ |
| Material | ||
| Advanced fiber composites that contain no | ||
| metal parts in the treatment area. | ✓ | ✓ |
| Biocompatibility | ✓ | ✓ |
| Interface functionalities | ||
| Mountable on treatment tables using plates | ||
| with mechanical fixation. | ✓ | ✓ |
| Mechanical properties | ||
| Meets the deflection requirements of IEC | ||
| 60976 ( |