hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K223794 · Cefla S.C. · OAS · Jan 17, 2023 · Radiology

Device Facts

• Record ID: K223794
• Device Name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
• Applicant: Cefla S.C.
• Product Code: OAS · Radiology
• Decision Date: Jan 17, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Device Story

Extra-oral X-ray system for dental/maxillofacial imaging; produces panoramic, cephalometric, and CBCT images. System uses X-ray tube generator and solid-state sensors (CMOS or amorphous silicon flat panel) to acquire digital image data. Device rotates around patient; collimates X-ray beam to region of interest to minimize dose. Patient sits or stands; stabilized by craniostat/cephalostat. Class 1 laser pointers define positioning. Operator uses control panel for exposure parameters and system status. Digital data processed into reconstructed images via NNT/iRYS software; transferred to computer for clinician review. Used in dental/clinical settings by physicians, dentists, or technologists. Supports diagnostic examination of teeth, jaws, TMJ, and cervical spine.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), radiation protection (IEC 60601-1-3), and image quality verification.

Technological Characteristics

Digital X-ray system; X-ray tube generator; CMOS (scintillator/direct conversion) and amorphous silicon flat panel sensors. Fan-beam (PAN/CEPH) and cone-beam (CBCT) geometry. Class 1 laser positioning. Connectivity via NNT/iRYS software. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60825-1, IEC 62304.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic imaging of the maxillofacial region, teeth, dental arches, jaws, skull, carpus, ENT structures, and cervical spine via panoramic, cephalometric, or CBCT radiography.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084)

Submission Summary (Full Text)

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January 17, 2023

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CEFLA S.C. % Lorenzo Bortolotti Regulatory Affairs Via Selice Provinciale 23/A Imola. BO 40026 ITALY

Re: K223794

Trade/Device Name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: December 19, 2022 Received: December 19, 2022

# Dear Lorenzo Bortolotti:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

2023.01.17
*Lu Jiang* 12:32:19 -05'00'

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)

#### K223794

#### Device Name

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Indications for Use (Describe)

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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| | 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92 | | | | | K223794 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------|--------------|--|---------|
| Submitter's Name: | CEFLA S.C. | | | | | |
| Address: | Via Selice Provinciale 23/a | | | | | |
| | Imola, BO 40026 ITALY | | | | | |
| | Tel. [phone] | | | | | |
| | Fax [phone] | | | | | |
| Establishment<br>Registration Number: | 3006610845 | | | | | |
| Contact Person: | Lorenzo Bortolotti, Regulatory Affairs | | | | | |
| Telephone Number: | [phone] | | | | | |
| Email Address: | [e-mail] | | | | | |
| Date prepared: | December 19th, 2022 | | | | | |
| Device name: | hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS | | | | | |
| Common Name: | Extra oral source, Panoramic, Cephalometric, Computed tomography X-ray system | | | | | |
| Device Classification<br>Name: | X-Ray, Tomography, Computed, Dental | | | | | |
| Regulation Number: | 21 CFR §892.1750 | | | | | |
| Device Class: | Class II | | | | | |
| Classification<br>Product Code: | OAS | | | | | |
| Subsequent Product<br>Code: | MUH | | | | | |
| Device Description: | The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device<br>is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084).<br>Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without<br>changing any of the basic safety, essential performances and functional features: | | | | | |
| | # | Device Name | Brand | Manufacturer | | |
| | 1 | hyperion X9 pro | myray | CEFLA S.C. | | |
| | 2 | NewTom GIANO HR | NewTom | CEFLA S.C. | | |
| | 3 | X-RADIUS TRIO PLUS | Castellini | CEFLA S.C. | | |

Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.

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| | Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator<br>and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed<br>tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying<br>radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be<br>adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the<br>adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters<br>such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient<br>stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and<br>exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The<br>images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images,<br>essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:<br>(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the<br>oral cavity;<br>(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);<br>(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and<br>maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support,<br>if equipped with the CBCT option.<br>The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. |
| Identification of<br>Predicate Device | The predicate device identified relating the substantial equivalence of the proposed device is:<br>Device Names: hyperion X9 Pro, NewTom GIANO HR, X-RADIUS TRIO PLUS<br>510(k) Number: K214084<br>Device Classification Name: X-Ray, Tomography, Computed, Dental<br>Applicant: CEFLA S.C.<br>Via Selice Provinciale 23/A<br>Imola, IT 40026<br>Regulation Number: 21 CFR §892.1750<br>Device Class: Class II<br>Classification Product Code: OAS<br>Subsequent Product Code: MUH |

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Substantial Both Proposed device and Predicate device (K214084) permit the aquisition of panoramic images (CEPH) and cone beam Equivalence computed tomography images (CBCT).

The proposed device is a change of the Cefla's own legally marketed predicate device: hyperion X9 Pro, NewTom GiANO HR, X-RADUS TRO PLUS (K214084).

This device change makes available for the acquisition of 2D images (PAN, CEPH) alternative solid-state X-ray detectors already used in the predicate device hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K214084).

The following cross reference table shows similarity and diversity aspects between the proposed device and the Predicate device.

| | Proposed Device | Predicate Device | Justification for Differences |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | hyperion X9 pro,<br>NewTom GiANO HR,<br>X-RADIUS TRIO PLUS | hyperion X9 pro,<br>NewTom GiANO HR,<br>X-RADIUS TRIO PLUS | |
| Manufacturer | CEFLA S.C. | CEFLA S.C. | |
| 510(K) No. | - | K214084 | |
| Figure | Image: Proposed Device | Image: Predicate Device | The external appearances and materials<br>between Proposed device and Predicate<br>device are identical. |
| Classification and indication for use | | | |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | No difference. |
| Regulatory Class | Class II | Class II | No difference. |
| Classification Product<br>Code | OAS (Classification Product code)<br>MUH (Subsequent Product code) | OAS (Classification Product code)<br>MUH (Subsequent Product code) | No difference. |
| Classification Name: | Computed Tomography X-ray System | Computed Tomography X-ray System | No difference. |
| | | | |
| Indication for use | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | No difference. |
| Performance features | | | |
| Performance<br>specification | Panoramic<br>Computed tomography<br>Cephalometric | Panoramic<br>Computed tomography<br>Cephalometric | No difference. |
| Patient population | Adult, Pediatric | Adult, Pediatric | No difference. |
| Exposition selectable | 2D: PAN, BTW (bitewing), DENT, SIN,<br>TMJ, CEPH | 2D: PAN, BTW (bitewing), DENT, SIN,<br>TMJ, CEPH | No difference. |
| | | | |
| Rated input | 20A @ 115V~ | 20A @ 115V~ | No difference. |
| | 12A @ 240V~ | 12A @ 240V~ |…