Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.

This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, physicists.

Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.

This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Device Description

Nanox.ARC X is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiographers, radiologists, and physicists

The Nanox.ARC X includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector of a scintillator-photodetector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package.

The Nanox.ARC X X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.

The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) clearance letter for Nanox.ARC X, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Key Observation: The provided document is a 510(k) Clearance Letter. These letters primarily address the "substantial equivalence" of a new device to a predicate device, rather than providing detailed clinical efficacy trial results as would be found in a Premarket Approval (PMA) application or a de novo classification request. This type of clearance often relies heavily on non-clinical bench testing and technological comparisons to demonstrate that the new device is as safe and effective as a legally marketed predicate.

Therefore, the information regarding in-depth clinical studies (like MRMC studies, specific ground truth methods, or detailed acceptance criteria for diagnostic accuracy) is limited or absent in this document because it's not typically required for a 510(k) clearance based on substantial equivalence to an existing device with similar technological characteristics. The focus is on demonstrating that the modifications to the predicate device (Nanox.ARC) do not negatively impact its safety or effectiveness.

Acceptance Criteria and Device Performance Assessment

Based on the provided document, the "acceptance criteria" are primarily framed around demonstrating that the modified device (Nanox.ARC X) is as safe and effective as its predicate (Nanox.ARC), despite minor technological changes. The proof relies heavily on non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary focused on substantial equivalence and technological comparison, the "acceptance criteria" are inferred from the types of non-clinical tests performed to ensure the new device functions as intended and is as safe and effective as the predicate. The "reported device performance" are the general conclusions drawn from these tests.

Acceptance Criterion (Inferred from testing performed)	Reported Device Performance
System Electrical Qualification	Functioned as intended.
System Performance	Functioned as intended.
Longevity and Consistency	Functioned as intended.
Tube Longevity and Reliability	Functioned as intended.
Functional Verification	Functioned as intended.
Motion Control	Functioned as intended.
Dimensional and Mechanical Properties	Functioned as intended.
Image Quality	Functioned as intended.
Tube Comparison CEI and Nanox Korea	Functioned as intended.
Human Factors Summary	Functioned as intended.
Phantom Validation	Functioned as intended.
Weight Considerations	Functioned as intended.
Transportation	Functioned as intended.
Software Verification and Validation	Functioned as intended.
Overall Safety and Effectiveness	Similar to predicate device.

Note: The level of detail provided in a 510(k) letter doesn't include specific quantitative metrics for each test, only a general statement that the system "functioned as intended" and overall safety/effectiveness are similar to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of patient data. The testing described primarily involves bench testing, phantom studies, and system-level verification and validation. There is no indication of a clinical test set involving human patients as one might expect for a diagnostic accuracy study.
Data Provenance: Not applicable in the context of clinical patient data for this 510(k) pathway, as no clinical tests were performed. The "data" comes from the results of the various non-clinical bench tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Since no clinical tests were performed on human patients and no diagnostic accuracy claims are being established through reader studies, there was no need for expert ground truth establishment for a clinical test set.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was explicitly NOT done. The document states: "No clinical tests were performed for the subject device." This type of study would be a clinical test.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was done.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: The document does not describe a standalone diagnostic accuracy study of an AI algorithm. The device is a tomographic X-ray system, not an AI diagnostic algorithm, although it does include "image reconstruction service" and "DICOMization services." These are intrinsic functionalities of the imaging system itself, not separate AI components whose standalone diagnostic performance would be evaluated. The "Software Verification and Validation" likely covers the functional correctness of these reconstruction algorithms.

7. The Type of Ground Truth Used for the Test Set

Type of Ground Truth: Not applicable for a clinical test set. The "ground truth" for the non-clinical tests would be the established engineering specifications, phantom measurements, and functional requirements against which the device's performance was measured (e.g., a known phantom structure for image quality, or expected electrical parameters for qualification).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This 510(k) is for a hardware device (X-ray system) with associated software for image reconstruction. It is not an AI/ML algorithm that undergoes a distinct "training" phase on a specific dataset for diagnostic interpretation. The image reconstruction algorithms are typically deterministic or based on established physics and signal processing, not on deep learning models trained on large image datasets.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of an AI/ML diagnostic algorithm for which ground truth would be established. The "ground truth" for the development of image reconstruction algorithms would be based on mathematical models, physical principles of X-ray interaction, and calibrated phantom data to optimize image quality and accuracy.

Summary

FDA 510(k) Clearance Letter - Nanox.ARC X

Page 1

April 16, 2025

Nano-x Imaging Ltd.
℅ Noa First
Regulatory Affairs Manager
94 Em Hamoshavot Road, Brosh building, Ofer Tech Park,
PO Box 3486
PETAH TIKVA, 4970602
ISRAEL

Re: K250850
Trade/Device Name: Nanox.ARC X
Regulation Number: 21 CFR 892.1740
Regulation Name: Tomographic x-ray system
Regulatory Class: Class II
Product Code: IZF, MQB
Dated: March 20, 2025
Received: March 21, 2025

Dear Noa First:

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 (the 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 available 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.

April 16, 2025

Nano-x Imaging Ltd.
℅ Noa First
Regulatory Affairs Manager
94 Em Hamoshavot Road, Brosh building, Ofer Tech Park,
PO Box 3486
PETAH TIKVA, 4970602
ISRAEL

Dear Noa First:

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K250850 - Noa First Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250850 - Noa First Page 3

assistance/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

Lu Jiang
Assistant Director
Diagnostic X-ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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K250850

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250850

Device Name
Nanox.ARC X

Indications for Use (Describe)

Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.

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)

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:

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"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."

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K250850

04/10/2024

510(k) SUMMARY

I. SUBMITTER

Applicant Name: NANO-X Imaging Ltd.
Applicant Address: 94 Em Hamoshavot Road, Brosh building, Ofer Tech Park, PO Box 3486, Petah Tikva, 4970602 Israel
Applicant Contact Telephone: +972-54-5225792
Applicant Contact: Ofir Koren, General Manager ARC Division
Applicant Contact Email: ofir.k@nanox.vision
Correspondent Contact Telephone: +972-50-4040698
Correspondent Contact: Noa First, Regulatory Affairs Manager
Correspondent Contact Email: noa.f@nanox.vision

II. DEVICE

Device Trade Name: Nanox.ARC X
Common Name: System, X-Ray, Tomographic
Classification Name: Tomographic x-ray system
Regulation Number: 892.1740
Product Code(s): IZF, MQB

III. PREDICATE DEVICE

Predicate #: K242395
Predicate Trade Name: Nanox.ARC
Product Code: IZF, MQB

IV. DEVICE DESCRIPTION

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K250850 Nanox.ARC X

V. INDICATIONS FOR USE

Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.

Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.

VI. INDICATIONS FOR USE COMPARISON

The subject and the predicate devices have the same indications for use.

VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON

Both the subject and predicate devices share the same fundamental operating and technological principles.

Both devices are tomosynthesis-based imaging systems designed to produce tomographic images of human anatomy, from a single tomographic sweep, adjunctive to conventional radiography, of adult patients in recumbent positions.

Both devices utilize sequentially activated cold-cathode X-ray sources, with identical internal tube geometry and spatial alignment with the same detector, and the Nanox.CLOUD reconstruction software.

The subject device maintains functional and technological equivalence to the predicate device while incorporating system-level refinements.

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K250850 Nanox.ARC X

Technological Characteristics Comparison Table

Item	Subject Device K250850	Predicate Device K242395	SE Justification
System Architecture	System electronics internally arranged	System electronics externally arranged	Similar - Both system architectures retain the same functionality and components.Internalization of system electronics previously housed externally to improve system integration and fit within clinical environments; enhanced internal layout with no impact on system functionality
ARC Imaging Ring	Gantry-based arc structure with square-rounded design	Gantry-based arc structure with rounded design	Similar - Spatial configuration and internal geometry preserved; enclosure shape adjusted to optimize integration
Number of X-ray sources	Five (5), alternately-switched X-ray sources	Same	-
X-ray Tube Housing Material	Glass	Ceramic	Similar - Both systems utilize identical cathode technology, MEMS electron source, anode design, focal spot size, exposure parameters, X-ray field size, and target angle.Modification in housing material; no impact on emission characteristics, cathode technology, exposure range, or performance
Patient Weight Allowance	150kg / 330 lbs.	Same	-
Patient Table Footprint	Optimized footprint	Larger footprint	Similar - Both tables serve the same function and are motor-driven

All modifications have been verified and validated and do not impact safety or effectiveness.

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K250850 Nanox.ARC X

Technological Characteristics Comparison Table

Item	Subject Device K250850	Predicate Device K242395	SE Justification
System Architecture	System electronics internally arranged	System electronics externally arranged	Similar - Both system architectures retain the same functionality and components.Internalization of system electronics previously housed externally to improve system integration and fit within clinical environments; enhanced internal layout with no impact on system functionality
ARC Imaging Ring	Gantry-based arc structure with square-rounded design	Gantry-based arc structure with rounded design	Similar - Spatial configuration and internal geometry preserved; enclosure shape adjusted to optimize integration
Number of X-ray sources	Five (5), alternately-switched X-ray sources	Same	-
X-ray Tube Housing Material	Glass	Ceramic	Similar - Both systems utilize identical cathode technology, MEMS electron source, anode design, focal spot size, exposure parameters, X-ray field size, and target angle.Modification in housing material; no impact on emission characteristics, cathode technology, exposure range, or performance
Patient Weight Allowance	150kg / 330 lbs.	Same	-
Patient Table Footprint	Optimized footprint	Larger footprint	Similar - Both tables serve the same function and are motor-driven

All modifications have been verified and validated and do not impact safety or effectiveness.

VIII. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS

In order to support substantial equivalence, the following bench testing were performed on the subject device:

System Electrical Qualification
System Performance
Longevity and Consistency
Tube Longevity and Reliability
Functional Verification
Motion Control
Dimensional and Mechanical Properties
Image Quality
Tube Comparison CEI and Nanox Korea
Human Factors Summary
Phantom Validation
Weight Considerations
Transportation
Software Verification and Validation

In all instances, Nanox.ARC X System functioned as intended.

No clinical tests were performed for the subject device.

Based on performance data, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device, demonstrating that the subject device is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.