(218 days)
No
The summary describes standard X-ray imaging and reconstruction techniques, including a novel slot-scanning method for 2D representations. There is no mention of AI or ML algorithms being used for image processing, analysis, or any other function. The performance studies focus on image quality and geometric accuracy, not on AI/ML performance metrics.
No
The device is described as an X-ray system intended for visualizing anatomical structures and generating 2-D representations for assessment of body axes and skeletal alignment, which serves a diagnostic purpose rather than a therapeutic one. The "True2scale Body Scan feature is not intended to be used for interventional purposes."
Yes
Explanation: The device is intended to visualize anatomical structures and for the assessment of body axes and skeletal alignment, which are diagnostic purposes.
No
The device description clearly states that the Multitom Rax is a stationary X-ray system consisting of hardware components like a patient table, X-ray tube, Solid State X-ray Imager, and an X-ray generator. While it includes digital imaging and post-processing, it is fundamentally a hardware-based imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Multitom Rax is an X-ray system that visualizes anatomical structures within the body using radiation. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes imaging procedures for various parts of the body and skeletal alignment, all of which are performed directly on the patient.
Therefore, the Multitom Rax falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Multitom Rax is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial. skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, art interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The Multitom Rax is not for mammography examinations.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
Product codes
OWB, JAA
Device Description
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended Xray tube and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
With the new True2scale Body Scan technology, the Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
gastrointestinal, cranial, skeletal, thoracic, lung, urogenital tract, spine, lower limbs, full body
Indicated Patient Age Range
pediatric, adult, and bariatric patients.
Intended User / Care Setting
Not Found
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
The evaluation of ten (10) anonymized clinical image sets by expert, board-certified radiologists has shown that all image sets were found to be of acceptable clinical image quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Testing was conducted with a metal ruler to present the linear movement of the system and the robustness for the intended application.
- X-ray exposure dose evaluations provide evidence of the low dose claim when compared to current technologies with tube tilt and image stitching.
- The evaluation of ten (10) anonymized clinical image sets by expert, board-certified radiologists has shown that all image sets were found to be of acceptable clinical image quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 18, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Siemens Medical Solutions % Ms. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K212212
Trade/Device Name: Multitom Rax with True2scale Body Scan Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: January 13, 2022 Received: January 14, 2022
Dear Ms. Adams:
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. 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 located 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212212
Device Name
Multitom Rax with True2scale Body Scan Option
Indications for Use (Describe)
Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric patients. The Multitom Rax is not for mammography examinations.
The True2scale Body Scan functionality (ie., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan feature is not intended to be used for interventional purposes.
| 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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510(k) Summary: Multitom Rax with True2scale Body Scan Option
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: January 10, 2022
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92.
1. General Information:
Importer / Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site:
Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US adams.denise@siemens-healthineers.com
Alternate Contact Person:
Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel@siemens-healthineers.com
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-
- Device Name and Classification :
| Trade Name: | Multitom Rax with True2Scale Body Scan Option |
|---|---|
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1650 |
| Device Class: | II |
| Product Code: | OWB |
| Secondary Product Code: | JAA |
-
- Legally Marketed Predicate Device:
| Trade Name | SONIALVISION G4 by SHIMADZU corporation |
|---|---|
| 510(k) Number | K190373 |
| Device | |
| Classification | |
| Name | Image-intensified fluoroscopic X-ray system |
| Regulation | |
| Number | 892.1650 |
| Review Panel | Radiology |
| Product Code | JAA |
| Device Class | 2 |
న. Device Description:
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended Xray tube and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
With the new True2scale Body Scan technology, the Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.
6. Indication for Use:
Multitom Rax is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial. skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency
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applications, lymphography, endoscopy, myelography, venography, art interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The Multitom Rax is not for mammography examinations.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
7. Substantial Equivalence:
The new feature True2scale Body Scan adds a term to the indication for use that is similar to the one of the predicate.
The device remains within the same classification for the same technology as the predicate device. The new system software design was completed in accordance with Siemens Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The subject device with the new software VF11 uses the same X-ray scanning technology as the predicate device. There are substantial differences in the mechanical design of the subject device as compared to the predicate device design. Additional testing was conducted to provide evidence for the robustness of the subject device. Tomosynthetic reconstruction provides a similar image result and there are similarities in the patient environment and the type of user interface.
The following table compares the main performance data of the subject device with the predicate device to substantiate equivalence of the subject device and predicate device.
Comparison of the Subject Device (Multitom Rax with True2scale Body Scan) to Predicate Device (SONIALVISION G4 by SHIMADZU corporation)
| Feature | Predicate device | Subject device | Comment |
|---|---|---|---|
| SONIALVISION G4 | |||
| (K190373) by | |||
| SHIMADZU corporation | Multitom Rax with | ||
| True2scale Body Scan | |||
| Regulation | |||
| Description | Image-intensified | ||
| fluoroscopic X-ray system | Image-intensified | ||
| fluoroscopic X-ray system | Same | ||
| Regulation | |||
| Number | 892.1650 | 892.1650 | Same |
| Classification | |||
| Product Code | JAA | OWB | The predicate |
| device is not | |||
| Subsequent | |||
| Product Code | N/A | JAA | for inter- |
| ventional use | |||
| therefore it | |||
| only has the | |||
| JAA procode | |||
| Indications | |||
| for use for the | |||
| Slot | |||
| technology | |||
| only | The equipment is intended | ||
| to be used for the | |||
| fluoroscopy/ radiography | |||
| diagnosis in hospital. | |||
| The equipment must only | |||
| be operated by qualified | |||
| personnel, such as | |||
| radiography technicians or | |||
| those with equivalent | |||
| qualificat-ions. The | |||
| equipment is used for total | |||
| patient population. | |||
| The equipment is NOT | |||
| intended to be used for | |||
| Mammography screening. | |||
| The equipment is NOT | |||
| intended to be used for | |||
| interventional procedure. | |||
| The equipment is used for | |||
| radiographic, fluoroscopic, | |||
| angiographic and pediatric | |||
| examinations. Stored | |||
| images in the equipment | |||
| can be used for re- | |||
| monitoring, image | |||
| processing, storing to | |||
| optical media (CD/DVD), | |||
| and sending to DICOM | |||
| server. | |||
| The Tomosynthesis | |||
| option for the | |||
| SONIALVISION G4 is | |||
| intended to generate | |||
| tomographic images of | |||
| human anatomy | Multitom Rax is a device | ||
| intended to visualize | |||
| anatomical structures by | |||
| converting an X-ray pattern | |||
| into a visible image. The | |||
| system has medical | |||
| applications ranging from | |||
| gastrointestinal examinations | |||
| to cranial, skeletal, thoracic | |||
| and lung exposures as well as | |||
| examinations of the | |||
| urogenital tract. The unit may | |||
| also be used in emergency | |||
| applications, lymphography, | |||
| endoscopy, myelography, | |||
| venography, arthrography, | |||
| interventional radiology, | |||
| digital angiography, and | |||
| digital subtraction | |||
| angiography (DSA). The | |||
| system may be used on | |||
| pediatric, adult, and bariatric | |||
| patients. | |||
| The True2scale Body Scan | |||
| feature employs a slot- | |||
| scanning-based acquisition | |||
| and reconstruction technique | |||
| to produce a 2D | |||
| representation of the scanned | |||
| object which is intended for | |||
| the assessment of body axes | |||
| and skeletal alignment. | |||
| The True2scale Body Scan | |||
| feature itself is not intended | The subject | ||
| device has a | |||
| broader range | |||
| of applications. | |||
| The | |||
| tomosynthesis | |||
| feature and the | |||
| subject of this | |||
| application is | |||
| similar to the | |||
| predicate | |||
| including chest or | |||
| extremities. | |||
| Tomosynthesis technique | |||
| is used to produce a | |||
| specific cross-sectional | |||
| plane of the body by | |||
| reconstruction of | |||
| tomographic acquisition. | |||
| The device is not intended | |||
| for mammographic | |||
| applications | to be used for interventional | ||
| purposes. | |||
| Mechanical | |||
| System design | Remotely controlled | ||
| Fluoroscopy Table | Twin robotic arms suspended | ||
| from ceiling with floor- | |||
| mounted table, remotely | |||
| controlled | Different | ||
| design requires | |||
| additional tests | |||
| for mechanical | |||
| integrity | |||
| X-ray beam | |||
| geometry | Slot technology | Slot technology | Same |
| High voltage | |||
| generator | 80 kW | 65 kW or 80 kW | Similar |
| X-Ray Tube | Max anode heat capacity | ||
| 750 kHU | |||
| Focal size: 0.7 / 1.2 mm | Max anode heat capacity 820 | ||
| kHU | |||
| Focal size: 0.6 / 1.0 mm | Similar | ||
| Slot imaging | |||
| coverage | Max.141cm × 42cm | Max.170cm × 43cm | Similar |
| X-ray detector | Solid State X-ray Imager | Solid State X-ray Imager | Same |
| Image | |||
| processing | Image reconstruction with | ||
| tomosynthesis | Image reconstruction with | ||
| tomosynthesis | Same | ||
| Image | |||
| geometry | True 1:1 in scan direction | True 1:1 in scan direction | Same |
| Slot width | 40 mm in HS mode | ||
| 40 mm in HO mode | 50 mm | Similar |
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Summary of Non-Clinical Tests: 9.
The software VF11 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. The following performance tests were conducted:
- Testing was conducted with a metal ruler to present the linear movement of the system and ● the robustness for the intended application
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Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.
- X-ray exposure dose evaluations provide evidence of the low dose claim when compared . to current technologies with tube tilt and image stitching.
10. Summary of Tests to comply with International Standards
The devices operating with software VF10 comply with the voluntary standards as listed in the following table:
| Standards Development
Organization
and
| Reference Number | Title of Standard |
|---|---|
| ANSI AAMI | |
| 60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: General |
| Requirements for Safety | |
| IEC 60601-1-2 2014 Ed 4.0 | Medical Electrical Equipment - Part 1-2: General |
| requirements for basic safety and essential performance - | |
| Collateral Standard: Electromagnetic Compatibility -- | |
| Requirements and Tests | |
| IEC 60601-1-3: | |
| Edition 2.1, 2013 | Medical electrical equipment - Part 1-3: General |
| requirements for basic safety and essential performance - | |
| Collateral Standard: Radiation protection in diagnostic X- | |
| ray equipment | |
| IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular |
| requirements for the basic safety and essential | |
| performance of X-ray tube assemblies for medical | |
| diagnosis | |
| IEC 60601-2-54 | |
| 2018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular |
| requirements for the basic safety and essential | |
| performance of X-ray equipment for radiography and | |
| radioscopy | |
| IEC 60601-1-6 | |
| 2013 Ed 3.1 | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Usability | |
| IEC 62366-1 2015 Ed 1.0 | Medical devices – Application of usability engineering to |
| medical devices | |
| ISO 14971: 2019 | Medical devices - application of risk management to |
| medical devices | |
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes |
| IEC 61910-1: 2014, Ed 1.0 | Medical electrical equipment |
| Radiation dose | |
| documentation - Part 1: Radiation dose structured reports | |
| for radiography and radioscopy | |
| NEMA PS 3.1 - 3.20 2016 | Digital Imaging and Communications in Medicine |
| (DICOM) Set | |
| IEC 60601-2-43: 2017 | Medical electrical equipment – Part 2-43: Particular |
| requirements for the safety of X-ray equipment for | |
| interventional procedures | |
| ISO EN ISO 15223-1 | |
| 2017-04 | Medical devices - Symbols to be used with medical |
| device labels, labelling and information to be supplied - | |
| Part 1: General requirements | |
| IEC 62220- | |
| 1-1:2015 | Medical electrical equipment – Characteristics of digital |
| X-ray imaging devices – Part 1-1: | |
| Determination of the detective quantum efficiency – | |
| Detectors used in radiographic imaging |
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11. Summarv of Clinical Tests:
For the subject of this premarket submission, Siemens did an evaluation of the clinical image quality as the True2scale Body Scan technology is new.
The purpose of this clinical image evaluation was to show that even though the two orthogonal views (a.p. & lateral) are acquired sequentially, the resulting images are correlating sufficiently to allow a detection and evaluation of the vertebral alignment in each projection plane.
The evaluation of ten (10) anonymized clinical image sets by expert, board-certified radiologists has shown that all image sets were found to be of acceptable clinical image quality.
12. General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed.
Furthermore, the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
13. Conclusion as to Substantial Equivalence:
The Multitom Rax with the True2scale Body Scan feature is intended for similar indications for use as the predicate device. There are substantial differences in the mechanical design of the subject device as compared to the predicate device design. Additional testing was conducted to provide evidence for the robustness of the subject device. The operating environment is the same and the technology similar. Siemens concludes via the documentation provided in this 510(k) submission that the True2scale Body Scan feature of the Multitom Rax is substantially equivalent to the predicate device SONIALVISION G4.
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14. Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:
Content of Premarket Submission for Management of Cybersecurity in Medical Devices -Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.
The 510(k) Program: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28. 2014