Who is the manufacturer of Nanox Cart X-ray System?

Nano-X Imaging , Ltd. filed the 510(k) submission for Nanox Cart X-ray System (K203782).

What is the FDA product code for Nanox Cart X-ray System?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Nanox Cart X-ray System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Nanox Cart X-ray System?

AMX-4 Mobile X-Ray System (K021016).

Who can help prepare an FDA 510(k) submission like Nanox Cart X-ray System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nanox Cart X-ray System

K203782 · Nano-X Imaging , Ltd. · IZL · Apr 1, 2021 · Radiology

Device Facts

Record ID	K203782
Device Name	Nanox Cart X-ray System
Applicant	Nano-X Imaging , Ltd.
Product Code	IZL · Radiology
Decision Date	Apr 1, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.

Device Story

Mobile X-ray system for point-of-care radiographic imaging of hands, wrists, and fingers. System comprises mobile enclosure, cold cathode X-ray tube, pulse generator, high-voltage generator, and touchscreen interface. Operator selects energy parameters (40kVp, 0.1–2mAs) via touchscreen; microprocessor manages exposure consistency. Device operates with specific Flat Panel Digital X-ray Detector (EVS3643). Used by trained healthcare professionals in clinical settings where patient transport to fixed imaging suites is impractical. Output is radiographic image data captured by external detector. System design includes emergency stop, isolation transformer, and cooling fluid for tube assembly. Benefits include portable diagnostic capability for extremity imaging.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and phantom imaging studies. Phantom study used anthropomorphic hand phantoms (Kyoto Kagaku) to compare output against predicate. Three experts evaluated images, concluding Nanox Cart output is equivalent to predicate. Bench testing verified electrical safety, electromagnetic compatibility, and radiation protection per IEC 60601 series standards.

Technological Characteristics

Mobile X-ray system; cold cathode X-ray tube; 40kVp fixed voltage; 0.1-2mAs variable charge; 0.3mm focal spot. Components: mobile cart, pulse generator, microprocessor, touchscreen LCD. Power: 240VAC/50Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 62304. Connectivity: Operates with external EVS3643 digital detector.

Indications for Use

Indicated for radiographic X-ray examinations of hands, wrists, and fingers in adult patients. Not for pediatric use, general radiography, mammography, angiography, interventional, or fluoroscopic applications.

Regulatory Classification

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.

Predicate Devices

AMX-4 Mobile X-Ray System (K021016)

Reference Devices

DRX-Revolution Nano Mobile X-ray System (K173924)
Flat Panel Digital X-ray Detector Model EVS3643 (K162552)

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Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 {4}------------------------------------------------ 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: 1) Cart – The mobile enclosure of the system. 2) 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). 3) On/Off Switch – A switch that switches the system on. 4) X-Ray Stop (Emergency | The AMX-4mobile X-ray system is comprised of the following components: 1) Cart 2) Collimator 3) Column 4) Power Connectors 5) Rotating Arm 6) Docking tube and docking receiver 7) E-Stop (Emergency Stop) knobs 8) Grid alignment system 9) PREP/EXP switch 10) Screen 11) Tube head assembly 12) 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. 5) X-Ray Switch – A switch that enables the X-ray radiation energy. 6) 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. 7) Controller – the Display and a micro-controller (Arduino Mega 256) controls the Nanox Cart X- ray System's functionality and GUI display. 8) Pulse Generator - The pulse generator enables a pulse of 40kVp and 0.1— 2mAs. 9) Isolation Transformer – Enables protection from power mains surges. 10) Power Supply – Power mains input of 230VAC/50Hz/300W. 11) 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. 12) 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: 1. 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 2. 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 |…