(94 days)
No
The summary describes a standard mobile X-ray system with a microprocessor for exposure consistency and a user interface. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for image analysis, interpretation, or system control beyond basic operational functions.
No
This device is an X-Ray source for diagnosis, intended to perform radiographic examinations. Its purpose is imaging for diagnostic purposes, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The product is intended as an X-Ray source for diagnosis." While the device itself is an X-ray source, its intended purpose is to generate images used by healthcare professionals for diagnosis.
No
The device description explicitly lists multiple hardware components including an X-Ray tube assembly, pulse generator, high-voltage generator, microprocessor, and touch-based screen LCD. It also states it operates with a specific Flat Panel Digital X-ray Detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nanox Cart X-Ray System is an X-ray source used to generate images of the human body (hands, wrists, and fingers) for diagnostic purposes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's an "X-Ray source for diagnosis" and for performing "radiographic X-Ray examinations." This is an in vivo (within the living body) diagnostic method, not in vitro.
Therefore, the Nanox Cart X-Ray System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
IZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
hands, wrists, and fingers
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment.
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)
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 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.
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.
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
§ 892.1720 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.
0
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
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 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
2
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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3
| Submission File | ||
|---|---|---|
| Nano-x Imaging Ltd. | ||
| Neve Ilan Communication Center, Zip 9085000, Israel | ||
| Telephone: +972-2-574-6300 | ||
| 510(k) Summary | K203782 | |
| Applicant: | Nano-x Imaging Ltd. | |
| Neve Ilan Communications Center | ||
| Jerusalem District | ||
| Israel, 9085000 | ||
| Phone: +972 (2) 574-6300 | ||
| Contact Person: | Yuval Shapiro | |
| QA/RA | ||
| Nano-x Imaging Ltd. | ||
| Phone: +972 (54) 205-2524 | ||
| Email: 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 System | |
| Mobile X-Ray Device | ||
| Mobile X-Ray system | ||
| 21 CFR 892.1720 | ||
| II | ||
| IZL | ||
| Predicate Device: | ||
| Manufacturer: | ||
| 510(k) Number: | ||
| Regulation Name: | ||
| Number: | ||
| Regulatory Class: | ||
| Product Code: | AMX-4 Mobile X-Ray System | |
| GE Medical Systems | ||
| K021016 | ||
| Mobile x-ray system | ||
| 21 CFR 892.1720 | ||
| II | ||
| IZL | ||
| Reference Device: | ||
| Manufacturer: | ||
| 510(k) Number: | ||
| Regulation Name: | ||
| Number: | ||
| Regulatory Class: | ||
| Product Code: | DRX-Revolution Nano Mobile X-ray System | |
| Carestream Health Inc. | ||
| K173924 | ||
| Mobile x-ray system | ||
| 21 CFR 892.1720 | ||
| II | ||
| IZL |
Nanox Cart X-Ray System – 510(k) Submission File
Page 1 of 8
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Image /page/4/Picture/0 description: The image shows a series of six distinct symbols or glyphs arranged horizontally. Each symbol is rendered in black against a white background, creating a stark contrast. The symbols appear to be abstract and geometric in nature, with varying shapes and orientations. The symbols include shapes resembling a horseshoe, an upside down V, and a square.
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.
5
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) | Significant
Difference |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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 to
perform radiographic X-Ray
examinations of hands, wrists,
and fingers, on adult patients. | The AMX-4 Plus Mobile X-ray
System is indicated for use in
generating radiographic images of
human anatomy in all general-
purpose X-ray diagnostic procedures.
It may be used in radiology
departments, emergency rooms,
intensive care units, operating rooms,
pediatrics, orthopedics, and clinics. | Similar |
| Intended
users | X-ray Technicians trained to
operate the system | X-ray Technicians trained to operate
the system | Same |
| Physical Characteristics | | | |
| System
Components | The Nanox Cart X-Ray System
is comprised of the following
components:
-
Cart – The mobile
enclosure of the system. -
Wheels and Breaks – Set
of 4 (four) wheels and
integral breaks that are
placed to enable the
mobility of the cart and
have a stationary
positioning during
operation (cart will not be
operated during movement). -
On/Off Switch – A switch
that switches the system on. -
X-Ray Stop (Emergency | The AMX-4mobile X-ray system is
comprised of the following
components: -
Cart
-
Collimator
-
Column
-
Power Connectors
-
Rotating Arm
-
Docking tube and docking
receiver -
E-Stop (Emergency Stop)
knobs -
Grid alignment system
-
PREP/EXP switch
-
Screen
-
Tube head assembly
-
X-Ray Tube | Similar |
| | Nanox Cart X-Ray System
(K203782) | AMX-4 Mobile X-Ray System
(K021016) | Significant
Difference |
| | that prevents the system
from operating, should the
operator determine to halt
procedure. -
X-Ray Switch – A switch
that enables the X-ray
radiation energy. -
Display - Operators display
of energy emitted by the
Nanox Cart. The display is
a touchscreen that enables
adjusting the energy pulse
(touchscreen) from 0.1mAs
up to 2mAs in steps of
0.1mAs. -
Controller – the Display
and a micro-controller
(Arduino Mega 256)
controls the Nanox Cart X-
ray System's functionality
and GUI display. -
Pulse Generator - The
pulse generator enables a
pulse of 40kVp and 0.1—
2mAs. -
Isolation Transformer –
Enables protection from
power mains surges. -
Power Supply – Power
mains input of
230VAC/50Hz/300W. -
Tube Assembly – The X-
ray tube assembly consists
of the X-ray Tube, Cooling
Fluid, electronics, and
casing to enable the
emission of the radiation
energy. -
X-ray Tube - Nano-x's
Cold Cathode tube. | | |
| Imaging
Radiographic
film cassette | The Nanox Cart is specified and
designed to operate only with a
Flat Panel Digital X-ray | Any commercially available
Radiographic film cassette | Different |
| | Nanox Cart X-Ray System
(K203782) | AMX-4 Mobile X-Ray System
(K021016) | Significant
Difference |
| | Detector Model EVS3643, manufactured by DRTECH Inc.
(K162552) | | |
| Technology | | | |
| Principles of
Operation | The positions of the Tube
Assembly and detector holder
are prefixed. The technician
positions the patient's hand
inside the indicated irradiation
area on the detector.
The technician sets the required
energy on the Display's
touchscreen. Irradiation energy
is set with a fixed radiographic
output voltage of 40kVp and a
variable charge of 0.1–2mAs.
Exposure time varies from
50ms up-to 1s (non-selectable).
Once energy is set, the
technician operates the system
by pressing the X-Ray switch. | The technician has the ability to
position the AMX-4's tube assembly
using the rotating arm. The AMX-4
is an all-inclusive device, where X-
ray images are constructed on its
Display.
The AMX-4 has a rechargeable array
of 12.9V batteries that has the ability
to operate the following methods:
- Two 70 kVp, 10 mAs X-ray
exposures, >7 seconds of
preparation, > 25 seconds of field
light, 5 minutes of drive time, 9
minutes of idle time - The AMX 4 batteries will provide
enough capacity for 165 or more 100
kVp, 100 mAs X-ray exposures.
Each exposure includes 4 seconds of
preparation time and 30 seconds of
idle time for battery recovery. This
number may be reduced by
additional idle time required for
X-ray tube cooling. | Different |
| System
Power | 240 VAC, 50 Hz | 100/200 VAC, 50/60 Hz | Same |
| Battery
Powered | 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 |
| Tube
Type/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 |
| Column
Rotation
Range | Fixed | (+/-)270 degrees | Different |
| | Nanox Cart X-Ray System
(K203782) | AMX-4 Mobile X-Ray System
(K021016) | Significant
Difference |
| Max Speed
(kph) | 4 | 4.8 | Similar |
| Horizontal
Travel (cm) | Fixed | 40.6 | Different |
| Vertical
Travel (cm) | Fixed | 138.4 | Different |
| Maximum
Tube Voltage | 40 kV | 100 kV | Different |
| Aperture
shape | Rectangular | Rectangular | Same |
| Aperture
Control | Fixed | Operator Adjustable | Different |
1 https://www.accessdata.fda.go, v/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?lD=K021016
6
«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
7
«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
8
«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 Nano
X-ray system | Significant
Difference |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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 CFR
892.1720 | Same |
| Product code | IZL | IZL | Same |
| Indications /
Intended use | The device is designed to
perform radiographic X-Ray
examinations of hands, wrists,
and fingers, on adult patients. | The device is designed to perform
radiographic x-ray examinations on
pediatric and adult patients, in all
patient treatment areas. | Similar |
| Intended
users | X-ray Technicians trained to
operate the system | X-ray Technicians trained to operate
the 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 and
7.7 kW @ 13 msec of power | Similar |
| Nominal
Voltage
Output | 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 |
| Tube
Type/Model | Nanox Tube | Xinray CNT Tube | Similar |
9
∩ ∧ ∩ □ ⋈
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 | ∩ | □ | □ | >