(94 days)
The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.
The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment.
The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a highvoltage generator; a microprocessor that provides increased exposure consistency and efficient operation; and a touch-based screen LCD which provides a simple and user-friendly interface and technique selection.
The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc. (K162552)
The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres to recognized and established industry practices and standards.
Here's a summary of the acceptance criteria and study information for the Nanox Cart X-ray System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of quantitative acceptance criteria from a clinical performance study. Instead, it relies on a qualitative assessment from a phantom imaging study. The implicit acceptance criterion from the phantom study is:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Images are "as good as an X-Ray system available in market" and "as good as images produced by the predicate Device." | The Nanox Cart is capable of supplying X-Rays to generate radiographies. Professional evaluation and comparison with a predicate device demonstrated the output images are "as good as" an X-Ray system available in the market and "as good as images produced by the predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to the use of "commercial products manufactured by Kyoto Kagaku" as phantoms. It doesn't specify a numerical sample size for the test set of phantoms. It states "The phantoms represent different hands."
- Data Provenance: The study was a phantom imaging study, not involving human subjects. The phantoms were "commercial products manufactured by Kyoto Kagaku." The study was conducted by Nano-x Imaging Ltd. (Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Three experts ("clinical evaluations of three experts")
- Qualifications of Experts: Not specified in the document.
4. Adjudication Method
The document states, "Professional evaluation of the output and professional comparison between the Nanox Cart X-Ray system and predicate device's output demonstrate that the outcome images of the Nanox Cart X-Ray system are as good as an X-Ray system available in market. Based on the clinical evaluations of three experts it can be concluded that the Nanox Cart X-Ray system operates as intended and generates images that are as good as images produced by the predicate Device."
This suggests a consensus or independent review by the three experts, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed. It appears to be a qualitative assessment leading to a conclusion of "as good as."
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
No MRMC comparative effectiveness study was mentioned. The device is an X-ray system, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an X-ray imaging system, not an algorithm, and is used with a human operator. The performance evaluation focused on the quality of the generated X-ray images.
7. The Type of Ground Truth Used
The ground truth for the phantom study was implicitly the inherent properties and known structures of the commercial phantoms. The evaluation by experts compared the generated images against a qualitative standard of "as good as" images from a predicate device or other market-available systems. This is more akin to expert consensus on image quality rather than a definitive pathology or outcomes data from patients.
8. The Sample Size for the Training Set
No training set is mentioned as this device is an X-ray imaging system, not an AI/ML algorithm that requires training data in the traditional sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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April 1, 2021
Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nano-x Imaging Ltd. % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street. Ste. 403 LUDLUM FL 33155
Re: K203782
Trade/Device Name: Nanox Cart X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: March 1, 2021 Received: March 24, 2021
Dear Rafael Aguila:
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
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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 mediation-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.
For
Thalia T. Mills, Ph.D. Director 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
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Indications for Use
510(k) Number (if known) K203782
Device Name Nanox Cart X-Ray System
Indications for Use (Describe)
The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healtheare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submission File | ||
|---|---|---|
| Nano-x Imaging Ltd.Neve Ilan Communication Center, Zip 9085000, IsraelTelephone: +972-2-574-6300 | ||
| 510(k) Summary | K203782 | |
| Applicant: | Nano-x Imaging Ltd.Neve Ilan Communications CenterJerusalem DistrictIsrael, 9085000Phone: +972 (2) 574-6300 | |
| Contact Person: | Yuval ShapiroQA/RANano-x Imaging Ltd.Phone: +972 (54) 205-2524Email: yuval.s@Nanox.vision | |
| Date Prepared: | Mar. 1, 2021 | |
| Device Trade Name:Device Common Name:Classification Name:Regulation Number:Regulation Class:Product Code: | Nanox Cart X-Ray SystemMobile X-Ray DeviceMobile X-Ray system21 CFR 892.1720IIIZL | |
| Predicate Device:Manufacturer:510(k) Number:Regulation Name:Number:Regulatory Class:Product Code: | AMX-4 Mobile X-Ray SystemGE Medical SystemsK021016Mobile x-ray system21 CFR 892.1720IIIZL | |
| Reference Device:Manufacturer:510(k) Number:Regulation Name:Number:Regulatory Class:Product Code: | DRX-Revolution Nano Mobile X-ray SystemCarestream Health Inc.K173924Mobile x-ray system21 CFR 892.1720IIIZL |
Nanox Cart X-Ray System – 510(k) Submission File
Page 1 of 8
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Nanox Cart X-Ray System - 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
Device Description:
The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment.
The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a highvoltage generator; a microprocessor that provides increased exposure consistency and efficient operation; and a touch-based screen LCD which provides a simple and user-friendly interface and technique selection.
The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc. (K162552)
The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres to recognized and established industry practices and standards.
Intended Use/Indications for Use:
The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.
Summary of Technology Characteristics:
Table 1 provides a comparison of the technological characteristics for the Nanox Cart X-Ray System and the predicate device.
Table 2 provides a comparison of the technological characteristics for the Nanox Cart X-Ray System and the reference device.
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UANOX
Nanox Cart X-Ray System - 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
Table 1: Comparison of Technological Characteristics
| Nanox Cart X-Ray System(K203782) | AMX-4 Mobile X-Ray System(K021016) | SignificantDifference | |
|---|---|---|---|
| Regulatory | |||
| 510(k) | K203782 | K021016¹ | |
| Device class | II | II | Same |
| Classification | Mobile x-ray system, Class II;21 CFR 892.1720 | Mobile x-ray system, Class II; 21 CFR 892.1720 | Same |
| Product code | IZL | IZL | Same |
| Indications /Intended use | The device is designed toperform radiographic X-Rayexaminations of hands, wrists,and fingers, on adult patients. | The AMX-4 Plus Mobile X-raySystem is indicated for use ingenerating radiographic images ofhuman anatomy in all general-purpose X-ray diagnostic procedures.It may be used in radiologydepartments, emergency rooms,intensive care units, operating rooms,pediatrics, orthopedics, and clinics. | Similar |
| Intendedusers | X-ray Technicians trained tooperate the system | X-ray Technicians trained to operatethe system | Same |
| Physical Characteristics | |||
| SystemComponents | The Nanox Cart X-Ray Systemis comprised of the followingcomponents:1) Cart – The mobileenclosure of the system.2) Wheels and Breaks – Setof 4 (four) wheels andintegral breaks that areplaced to enable themobility of the cart andhave a stationarypositioning duringoperation (cart will not beoperated during movement).3) On/Off Switch – A switchthat switches the system on.4) X-Ray Stop (Emergency | The AMX-4mobile X-ray system iscomprised of the followingcomponents:1) Cart2) Collimator3) Column4) Power Connectors5) Rotating Arm6) Docking tube and dockingreceiver7) E-Stop (Emergency Stop)knobs8) Grid alignment system9) PREP/EXP switch10) Screen11) Tube head assembly12) X-Ray Tube | Similar |
| Nanox Cart X-Ray System(K203782) | AMX-4 Mobile X-Ray System(K021016) | SignificantDifference | |
| that prevents the systemfrom operating, should theoperator determine to haltprocedure.5) X-Ray Switch – A switchthat enables the X-rayradiation energy.6) Display - Operators displayof energy emitted by theNanox Cart. The display isa touchscreen that enablesadjusting the energy pulse(touchscreen) from 0.1mAsup to 2mAs in steps of0.1mAs.7) Controller – the Displayand a micro-controller(Arduino Mega 256)controls the Nanox Cart X-ray System's functionalityand GUI display.8) Pulse Generator - Thepulse generator enables apulse of 40kVp and 0.1—2mAs.9) Isolation Transformer –Enables protection frompower mains surges.10) Power Supply – Powermains input of230VAC/50Hz/300W.11) Tube Assembly – The X-ray tube assembly consistsof the X-ray Tube, CoolingFluid, electronics, andcasing to enable theemission of the radiationenergy.12) X-ray Tube - Nano-x'sCold Cathode tube. | |||
| ImagingRadiographicfilm cassette | The Nanox Cart is specified anddesigned to operate only with aFlat Panel Digital X-ray | Any commercially availableRadiographic film cassette | Different |
| Nanox Cart X-Ray System(K203782) | AMX-4 Mobile X-Ray System(K021016) | SignificantDifference | |
| Detector Model EVS3643, manufactured by DRTECH Inc.(K162552) | |||
| Technology | |||
| Principles ofOperation | The positions of the TubeAssembly and detector holderare prefixed. The technicianpositions the patient's handinside the indicated irradiationarea on the detector.The technician sets the requiredenergy on the Display'stouchscreen. Irradiation energyis set with a fixed radiographicoutput voltage of 40kVp and avariable charge of 0.1–2mAs.Exposure time varies from50ms up-to 1s (non-selectable).Once energy is set, thetechnician operates the systemby pressing the X-Ray switch. | The technician has the ability toposition the AMX-4's tube assemblyusing the rotating arm. The AMX-4is an all-inclusive device, where X-ray images are constructed on itsDisplay.The AMX-4 has a rechargeable arrayof 12.9V batteries that has the abilityto operate the following methods:1. Two 70 kVp, 10 mAs X-rayexposures, >7 seconds ofpreparation, > 25 seconds of fieldlight, 5 minutes of drive time, 9minutes of idle time2. The AMX 4 batteries will provideenough capacity for 165 or more 100kVp, 100 mAs X-ray exposures.Each exposure includes 4 seconds ofpreparation time and 30 seconds ofidle time for battery recovery. Thisnumber may be reduced byadditional idle time required forX-ray tube cooling. | Different |
| SystemPower | 240 VAC, 50 Hz | 100/200 VAC, 50/60 Hz | Same |
| BatteryPowered | No | Yes | Different |
| kV Range | 40 kVp | 50-125 kVp, in 24 steps | Different |
| mAs Range | 0.1 to 2mAs, in 0.1mAs step | 0.40 to 320 mAs, in 30 steps | Different |
| TubeType/Model | Nanox Tube | GE X-Ray tube model HRT09 | Similar |
| Focal Spot | 0.3 mm | 0.6/2.0 mm | Similar |
| Target Angle | 0 degrees | 15 degrees | Similar |
| ColumnRotationRange | Fixed | (+/-)270 degrees | Different |
| Nanox Cart X-Ray System(K203782) | AMX-4 Mobile X-Ray System(K021016) | SignificantDifference | |
| Max Speed(kph) | 4 | 4.8 | Similar |
| HorizontalTravel (cm) | Fixed | 40.6 | Different |
| VerticalTravel (cm) | Fixed | 138.4 | Different |
| MaximumTube Voltage | 40 kV | 100 kV | Different |
| Apertureshape | Rectangular | Rectangular | Same |
| ApertureControl | Fixed | Operator Adjustable | Different |
1 https://www.accessdata.fda.go, v/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?lD=K021016
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«OUWU
Nanox Cart X-Ray System – 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
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«OUWU
Nanox Cart X-Ray System – 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
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«OUWU
Nanox Cart X-Ray System - 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
Table 2: Subject and Reference Device (DRX-Revolution Nano X-ray system) Comparison
| Nanox Cart X-Ray System(K203782) | DRX-Revolution NanoX-ray system | SignificantDifference | |
|---|---|---|---|
| Regulatory | |||
| 510(k) | K203782 | K173924 | |
| Device class | II | II | Same |
| Classification | Mobile x-ray system, Class II;21 CFR 892.1720 | Mobile x-ray system, Class II; 21 CFR892.1720 | Same |
| Product code | IZL | IZL | Same |
| Indications /Intended use | The device is designed toperform radiographic X-Rayexaminations of hands, wrists,and fingers, on adult patients. | The device is designed to performradiographic x-ray examinations onpediatric and adult patients, in allpatient treatment areas. | Similar |
| Intendedusers | X-ray Technicians trained tooperate the system | X-ray Technicians trained to operatethe system | Same |
| Technology | |||
| System Power | 240 VAC, 50 Hz | 100 – 240 V, 50/60 Hz | Same |
| Power output | 0.08kW | Maximum 4.8 kW @ 104 msec and7.7 kW @ 13 msec of power | Similar |
| NominalVoltageOutput | 40kVp | 40 kVp to 110 kVp | Similar |
| Nominal mAs | 0.1/2mAs | 0.2 mAs to 20 mAs | Similar |
| kV Range | Fixed: 40 kVp | 40 kVp to 110 kVp | different |
| mAs Range | 0.1 to 2mAs, in 0.1mAs step | 0.2 to 20.0 mAs | Similar |
| TubeType/Model | Nanox Tube | Xinray CNT Tube | Similar |
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∩ ∧ ∩ □ ⋈
Nanox Cart X-Ray System - 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
| Tube Weight | 0.4 kg | 1.1 kg | Similar |
|---|---|---|---|
| Focal Spot | 0.3 mm | 0.9 mm to 1.9 mm | Different |
| Target Angle | 16 deg | 14deg | Similar |
Performance Data
Bench testing
The complete system has been assessed and tested at the factory and by Standards testing facilities. The System passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by Nano-x, and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
The following Standards were used to test the System, has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
- Nanox Cart X-Ray System Verification testing
- . Software verification and validation (ISO 62304:2006 + A1:2015)
- Preclinical Comparison Tests
- . Ergonomic testing (IEC60601-1-6, IEC62366)
- Electrical Safety Testing (IEC 60601-1, IEC 62304:2006 + A1:2014)
- Electromagnetic Compatibility (IEC 60601-1-2 Ed. 4)
- . IEC/EN 60601-1: 2005 + AMD1: 2012 (3.1 Ed.) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- . IEC 60601-1-3: 2008 + AMD1: 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 60601-2-54:2009+AMD1:2015+AMD2:2018 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
in accordance with section 514(c)(1)(A) of the FD&C Act as outlined in "Medical X-ray Imaging Devices: Conformance with IEC Standards," dated May 2019.
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| ∩ | Λ | ∩ | □ | □ | >< |
|---|---|---|---|---|---|
| --- | --- | --- | --- | --- | ---- |
Nanox Cart X-Ray System - 510(k) Submission File
Nano-x Imaging Ltd. Neve Ilan Communication Center, Zip 9085000, Israel Telephone: +972-2-574-6300
The diagnostic imaging performance of the Nanox Cart X-Ray system was evaluated by executing a phantom imaging study. The phantoms used for the imaging study were commercial products manufactured by Kyoto Kagaku and intended for X-Ray imaging tests. The phantoms represent different hands and are anthropomorphic both in appearance, size, and X-Ray attenuation characteristics.
Performance output shows that the Nanox Cart is capable of supplying X-Rays to generate radiographies. Professional evaluation of the output and professional comparison between the Nanox Cart X-Ray system and predicate device's output demonstrate that the outcome images of the Nanox Cart X-Ray system are as good as an X-Ray system available in market. Based on the clinical evaluations of three experts it can be concluded that the Nanox Cart X-Ray system operates as intended and generates images that are as good as images produced by the predicate Device.
Clinical testing
Nano-x Imaging Ltd. does not believe that clinical data is necessary to support the determination that the Nanox Cart X-ray System is substantially equivalent to the bench testing described above is very comprehensive and demonstrates that the system meets its performance specifications. Specifically, the bench testing demonstrated the ability of the system to emit X-ray radiation as determined in its specifications.
The testing demonstrated that the product meets its performance specifications and performs as intended. In addition, the Nanox Cart X-Ray System was found to be substantially equivalent to the predicate device as it has the same indications for use and compliance with similar standards.
Substantial Equivalence Discussion:
The indications for use for the predicate device are similar to the proposed indications for use for the Nanox Cart X-Ray System. The technical characteristics of the System are not different from the predicate device except for the fixed Source-to-image Distance, Field of view, aperture, focal spot size, and the fixed Tube voltage and reduced maximum exposure current-time product. As demonstrated in Table 1 above, any differences in the technological characteristics do not raise any questions of safety or effectiveness.
The generated X-ray beams by both devices are the same, resulting with similar images generated by the devices. Thus, rendering the Nanox Cart X-Ray System substantially equivalent to the predicate device.
Conclusions
Extensive bench testing was conducted, which demonstrated that the Nanox Cart X-Ray System meets its performance specifications. This collection of testing demonstrates the safety and effectiveness of the Nanox Cart X-Ray System and its substantial equivalence to the predicate device.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.