(27 days)
Not Found
No.
The document does not mention the use of AI, DNN, or ML models in the device's functionality. The image reconstruction is described as "automatically reconstructed," which does not inherently imply AI.
No
The device is an imaging system (X-ray) used for diagnostic purposes, not for treating or interventional therapy.
Yes
Explanation: The device is intended to produce tomographic images for general use, including the human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, which are used by radiologists to diagnose conditions.
No
The device description clearly outlines hardware components such as a floor-mounted system, arc gantry with five identical tubes, a motorized patient table, and a flat panel detector. While it mentions image reconstruction and DICOMization services (software functions), these are part of a larger physical X-ray system. The performance studies also include hardware-related testing like "System Electrical Qualification," "Tube Longevity and Reliability," and "Dimensional and Mechanical Properties."
No.
The device is an X-ray system used for producing tomographic images of anatomical sites, which is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
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, and 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.
Product codes
IZF, MQB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Tomographic X-ray
Anatomical Site
human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus
Indicated Patient Age Range
adult patients
Intended User / Care Setting
professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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.
Page 2
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-
Page 3
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
Page 4
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)
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, and 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.
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:
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."
Page 5
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
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.
Page 6
K250850 Nanox.ARC X
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.
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.
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, and 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.
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.
Page 7
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.
Page 8
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.