Nanox.ARC

K222934 · Nano-X Imaging , Ltd. · IZF · Apr 28, 2023 · Radiology

Device Facts

• Record ID: K222934
• Device Name: Nanox.ARC
• Applicant: Nano-X Imaging , Ltd.
• Product Code: IZF · Radiology
• Decision Date: Apr 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1740
• Device Class: Class 2

Intended Use

Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system 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 Tomosynthesize 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, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Device Story

Nanox.ARC is a floor-mounted, stationary tomographic X-ray system for musculoskeletal imaging. It utilizes a tilting arc gantry with five independently, electronically switched cold-cathode X-ray tubes (MEMS-based quantum tunneling) operated sequentially to acquire multiple low-dose projections during a single non-linear spherical sweep. Input data from a flat-panel scintillator-photodetector is processed by a reconstruction engine to generate tomographic slices parallel to the table plane. The system is operated by radiographers, radiologists, or physicists in professional healthcare settings. Image reconstruction, protocol management, and DICOMization services can be performed locally or via Nanox.CLOUD. The output provides depth information on structures of interest, reducing overlying structure interference to assist clinicians in diagnostic decision-making. The device features a motorized patient table and is controlled via a tablet interface.

Clinical Evidence

No clinical trials performed. Evidence consists of non-clinical bench testing, phantom performance evaluations, and a clinical sample evaluation. Nine digital tomosynthesis cases from healthy adult subjects and twelve phantom exams were used to confirm diagnostic quality and performance against standard-of-care radiography.

Technological Characteristics

Stationary tomographic X-ray system; cold-cathode X-ray source (MEMS chip, quantum tunneling); five X-ray tubes; flat-panel scintillator-photodetector; 43x43cm fixed field size; 1.8kW generator; 40-110 kVp range; PMMA tabletop; DICOM connectivity; local or cloud-based processing; Ubuntu 20.04 LTS OS; tablet-based control console. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, ISO 10993-1, ISO 14971, IEC 62366.

Indications for Use

Indicated for adult patients requiring tomographic imaging of the musculoskeletal system as an adjunct to conventional radiography. Contraindicated for pediatric/neonatal patients and mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, interventional, or fluoroscopic applications.

Regulatory Classification

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.

Predicate Devices

• DR 600 with Tomosynthesis (K193262)

Reference Devices

• DR 800 with Tomosynthesis (K183275)

Submission Summary (Full Text)

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April 28, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Nano-X Imaging Ltd. % Odelia Maron VP QA & RA Communications Center, Bldg. C. Entrance 1 Neve Ilan. 9085000 ISRAEL

# Re: K222934

Trade/Device Name: Nanox.ARC Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, MQB Dated: March 27, 2023 Received: March 27, 2023

Dear Odelia Maron:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological 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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# Indications for Use

510(k) Number (if known) K22934

Device Name Nanox.ARC

## Indications for Use (Describe)

Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system 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 Tomosynthesize 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, cardiac, pulmonary, intra-abdominal, intra-cranial, 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*)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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# Nanox.ARC 510(k) Summary

K222934

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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K222934" in a simple, sans-serif font. The characters are black against a white background. The text appears to be a code or identifier, possibly a serial number or product code.

Image /page/5/Picture/1 description: The image shows the logo for Nanox. The logo consists of a blue, abstract design that resembles a stylized globe or sphere, composed of interconnected lines. Below the design, the word "NANOX" is written in a bold, blue sans-serif font.

#### Submission Sponsor 1

Nano-x Imaging Ltd. Communications Center, Bldg. C, Entrance 1, Neve Ilan, Israel 9085000 Establishment Registration Number: The Company will register following FDA clearance

#### 2 Submission Correspondent

Odelia Maron, Ph.D. VP QA & RA Phone: [phone] E-mail: [e-mail]

#### 3 Date Prepared

March 24, 2023

#### 4 Device identification

| Name of Device: | Nanox.ARC |
|------------------------------|--------------------------|
| Classification Name: | Tomographic X-ray System |
| Regulation: | 21 CFR §892.1740 |
| Regulatory Classification: | Class II |
| Product Classification Code: | IZF and MQB |
| Classification panel: | Radiology |

#### 5 Legally Marketed Predicate and Reference Device

| Predicate Manufacturer: | AGFA NV. |
|--------------------------------|---------------------------|
| Predicate Trade Name: | DR 600 with Tomosynthesis |
| Predicate Classification Code: | IZF and MQB |
| Predicate 510(k): | K193262 |
| Reference Manufacturer: | AGFA NV. |
| Reference Trade Name: | DR 800 with Tomosynthesis |
| Reference Classification Code: | IZF and JAA |
| Reference 510(k): | K183275 |

#### 6 Device description

Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients.

Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages.

Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. 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 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 image reconstruction service, as well as the system's protocol database and DICOMization

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Image /page/6/Picture/0 description: The image features the logo for Nanox, a company specializing in medical imaging technology. The logo consists of a stylized, abstract design in blue, resembling a symmetrical, curved pattern. Below the graphic is the word "NANOX" in a bold, sans-serif font, also in blue, clearly identifying the company.

services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.

#### 7 Indications for Use

Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system 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, pulmonary, intraabdominal, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

#### 8 Technological Characteristics

Nanox.ARC is a stationary X-ray tomographic system utilizes predefined protocols with predefined optimal acquisition parameters depending on the anatomy being imaged. The System allows the user to further configure these parameters for each examination type.

The acquired projection imaging data is automatically reconstructed to form tomographic imaged object.

A reconstruction engine converts the 2D images from the detector into Tomographical layers data. This reconstruction engine, as well as the system's protocol database and DICOMization services, can be hosted either locally, or as part of the Nanox.CLOUD.

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Image /page/7/Picture/0 description: The image features the logo for Nanox. The logo consists of a stylized blue graphic above the word "NANOX" in a simple sans-serif font. The graphic is composed of curved lines that intersect to form a pattern resembling a stylized eye or a network of interconnected pathways.

#### 9 Substantial Equivalence

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence with respect to indications for use, principles of operation, technological characteristics, materials, and performance.

The comparison of the devices in Table 1 below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new or different questions of safety or effectiveness based on the similarities to the predicate device.

| | Table 1 – Comparison of Subject Device with Predicate Device | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device<br>Nanox.ARC | Predicate Device<br>DR 600 with Tomosynthesis |
| Name | Nanox.ARC | DR 600 with Tomosynthesis |
| Manufacturer | Nano-x Imaging Ltd. | AGFA NV |
| 510(k) | K222934 | K193262 |
| Date of clearance | To be assigned | March 9, 2020 |
| Indications for use | Nanox.ARC is a stationary X-ray<br>system intended to produce<br>tomographic images of the human<br>musculoskeletal system adjunctive<br>to conventional radiography, on<br>adult patients.<br><br>This device is intended to be used<br>in professional healthcare facilities<br>or radiological environments, such<br>as hospitals, clinics, imaging<br>centers, and other medical<br>practices by trained radiographers,<br>radiologists, and physicists.<br><br>Digital Tomosynthesis is used to<br>synthesize tomographic slices from<br>a single tomographic sweep.<br><br>Applications can be performed<br>with the patient in prone, supine,<br>and lateral positions.<br><br>This device is not intended for<br>mammographic, angiographic,<br>cardiac, pulmonary, intra-<br>abdominal, intra-cranial,<br>interventional, or fluoroscopic<br>applications. This device is not<br>intended for imaging pediatric or<br>neonatal patients. | The DR 600 System is a general<br>radiography X-ray imaging system used<br>in hospitals, clinics and medical<br>practices by radiographers, radiologists<br>and physicists to make, process and<br>view static X-ray radiographic images<br>of the skeleton (including skull, spinal<br>column and extremities), chest,<br>abdomen and other body parts on adult,<br>pediatric or neonatal patients. In<br>addition, the System provides the<br>AGFA tomosynthesis option, intended<br>to acquire tomographic slices of human<br>anatomy and to be used with AGFA DR<br>X-ray systems. Digital Tomosynthesis<br>is used to synthesize tomographic slices<br>from a single tomographic sweep.<br>Applications can be performed with the<br>patient in a sitting, standing or lying<br>position. This System is not intended<br>for mammography applications. |
| Intended users | Radiographers, radiologists, and<br>physicists | Radiographers, radiologists, and<br>physicists |
| Intended use environment | Hospitals, clinics, imaging centers,<br>and other healthcare facilities | Hospitals, clinics, imaging centers, and<br>other healthcare facilities |
| Classification Name | Tomographic X-ray system | Tomographic X-ray system |
| Regulation number | 21 CFR § 892.1740 | 21 CFR § 892.1740 |
| Regulatory class | II | II |
| Product code | IZF, MQB | IZF, MQB |
| Item | Subject Device | Predicate Device |
| | Nanox.ARC | DR 600 with Tomosynthesis |
| Communications with | DICOM | DICOM |
| external storage devices | | |
| Patient positioning options | | |
| Vertical stand | Not included | Included as an Option |
| Table stand | Included | Included as an Option |
| Patient Table | | |
| Patient table height | 48cm<br>(motorized w/fixed height) | 55-90 cm<br>(motorized w/ height adjustment) |
| Patient weight allowance<br>(kg/lbs.) | 150kg / 330 lbs. | 320 Kg / 705 lbs. |
| Table length (mm) | 2600 | 2200 |
| Table width (mm) | 720 | 810 |
| Tabletop material | PMMA | Resopal HPL (DIN EN438) |
| Generator | | |
| Tube voltage range (kVp) | 40-110 | 40-150 |
| Nominal electric power<br>(kW) | 1.8 | Selectable 50, 65 or 80 |
| Total mAs range per<br>Tomosynthesis study | 12-90 mAs | 12-90 mAs |
| X-ray accuracy | Fulfills the X-ray radiation<br>accuracy according to EN IEC<br>60601-2-54 with a variation of<br>max. 0.05 (5%). | Fulfills the X-ray radiation accuracy<br>according to EN IEC 60601-2-54 with a<br>variation of max. 0.05 (5%). |
| X-ray source | | |
| Electron stream source | MEMS chip | Tungsten filament |
| Physical phenomena<br>generating electron<br>stream | Quantum tunneling via an applied<br>External electrical field (cold<br>cathode) | Thermionic excitation (Hot Cathode) |
| Focal spot size (nominal<br>FS value large/small<br>focus) | 0.7 | E7884X: 0.6/1.2<br>E7252X: 0.6/1.2<br>E7254FX: 0.6/1.2<br>E7869XX: 0.6/1.2 |
| Anode design | Stationary Anode…