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

K214084 · Cefla S.C. · OAS · Jan 20, 2022 · Radiology

Device Facts

• Record ID: K214084
• Device Name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
• Applicant: Cefla S.C.
• Product Code: OAS · Radiology
• Decision Date: Jan 20, 2022
• 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 (panoramic, cephalometric, CBCT) for maxillofacial imaging; utilizes X-ray tube generator and solid-state detectors (CMOS with scintillator or direct conversion CMOS for 2D; amorphous silicon flat panel for 3D). Device rotates around patient (sitting or standing) following specific trajectories; collimates beam to region of interest to minimize dose. Class 1 laser pointers assist positioning. Control panel manages exposure parameters and unit status. Digital data processed into reconstructed images; transferred to computer via NNT/iRYS software. Used by physicians, dentists, and technologists in clinical settings. Provides diagnostic support for dental, ENT, and maxillofacial conditions; enables precise anatomical visualization for treatment planning.

Clinical Evidence

No clinical studies performed. Substantial equivalence supported by 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; 2D CMOS sensors (scintillator or direct conversion) and 3D amorphous silicon flat panel. Focal spot 0.5mm (IEC 60336). Connectivity: PC-based image management. Software: NNT/iRYS. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60825-1.

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 (K190496)
• NewTom GiANO HR (K190496)
• X-RADIUS TRIO PLUS (K190496)

Submission Summary (Full Text)

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January 20, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name "U.S. Food & Drug Administration" in a smaller font size.

CEFLA S.C. % Mr. Lorenzo Bortolotti Via Selice Provinciale 23/a Imola, BO 40026 ITALY

Re: K214084

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, MUH Dated: December 20, 2021 Received: December 27, 2021

Dear Mr. 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 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

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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 medical devices and radiation-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,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K214084

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 (TMI), 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### CEFLA S.C. Special 510(k) Premarket Notification

### 510(k) SUMMARY as required by 21 cfr 807.92

Submitter's Name: CEFLA S.C. Address: Via Selice Provinciale 23/a Imola, BO 40026 ITALY Tel. [phone] Fax [phone] Establishment Registration Number: 3006610845 Lorenzo Bortolotti, Regulatory Affairs Contact Person: Telephone Number: [phone] Email Address: [e-mail] December 15th, 2021 Date prepared: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Device name: Common Name: Extra oral source, Panoramic, Cephalometric, Computed tomography X-ray system Device Classification Computed Tomography X-ray System Name: Regulation Number: 21 CFR §892.1750 Device Class: Class II Classification OAS Product Code: Subsequent Product MUH Code: The Proposed device is a panoramic, cephalometric andiological system developed and manufactured by CEFLA S.C. The proposed device Device Description: is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features: Manufacturer Device Name Brand # CEFLA S.C. ਜ |hyperion X9 pro myray 2 NewTom GiANO HR CEFLA S.C. NewTom 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, NewTom GiANO HR and X-RADiUS TRiO PLUS.

K214084

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| | Like the predicate device hyperion X9 pro (K190496) the proposed device is equipped with X-ray tube generator and X-ray sensors (solid state X-ray imaging<br>detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device permits to<br>acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient<br>following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the<br>radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-<br>ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure<br>technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient, stabilized through adjustable patient<br>supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers<br>information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a<br>computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT<br>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>(I) 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: K190496<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 hyperion X9 pro (K190496) permit the aquisition of panoramic images (CEPH) Equivalence

and cone beam computed tomography images (CBCT).

The proposed device is a change of the Cefla's own legally marketed predicate device: hyperion X9 pro (K190496). This device change makes available for the acquisition of 2D images (PAN, CEPH) alternative X-ray Direct conversion sensors in addition to the X-ray

Scintillator sensors (detectors) already used in the predicate device hyperion X9 pro (K190496).

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

| Device Name | Proposed Device | Predicate Device (A) | Justification for Differences |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 | K190496 | |
| 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<br>System | Computed Tomography X-ray<br>System | No difference. |
| Indication for use | The device is a digital panoramic,<br>cephalometric and tomographic<br>extra-oral X-ray system, intended to:<br>(I) produce orthopanoramic images<br>of the maxillofacial region and carry<br>out diagnostic examination on teeth,<br>dental arches and other structures in<br>the oral cavity;<br>(II) produce radiographs of jaws,<br>parts of the skull and carpus for the<br>purpose of cephalometric<br>examination, if equipped with tele-<br>radiographic arm (CEPH);<br>(III) the production of tomographic<br>images of the head, including the<br>ear, nose and throat (ENT), of the<br>dento-maxillo-facial complex, teeth,<br>mandible and maxilla,<br>temporomandibular-articular joint<br>(TMJ), other areas of the human skull<br>and neck with sections of the cervical<br>spine for use in diagnostic support, if<br>equipped with the CBCT option.<br>The device is operated and used by<br>physicians, dentists, x-ray<br>technologists and other legally<br>qualified professionals. | The device is a digital panoramic,<br>cephalometric and tomographic<br>extra-oral X-ray system, intended to:<br>(I) produce orthopanoramic images<br>of the maxillofacial region and carry<br>out diagnostic examination on teeth,<br>dental arches and other structures in<br>the oral cavity;<br>(II) produce radiographs of jaws,<br>parts of the skull and carpus for the<br>purpose of cephalometric<br>examination, if equipped with tele-<br>radiographic arm (CEPH);<br>(III) the production of tomographic<br>images of the head, including the ear,<br>nose and throat (ENT), of the dento-<br>maxillo-facial complex, teeth,<br>mandible and maxilla,<br>temporomandibular-articular joint<br>(TMJ), other areas of the human skull<br>and neck with sections of the cervical<br>spine for use in diagnostic support, if<br>equipped with the CBCT option.<br>The device is operated and used by<br>physicians, dentists, x-ray<br>technologists and other legally<br>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,<br>SIN, TMJ, CEPH<br>3D: Computed Tomography (CBCT) | 2D: PAN, BTW (bitewing), DENT,<br>SIN, TMJ, CEPH<br>3D: Computed Tomography (CBCT) | No difference. |
| | Technical & Functional features comparison: Rated input | | |
| Rated input | 20A @ 115V~<br>12A @ 240V~<br>50/60 Hz | 20A @ 115V~<br>12A @ 240V~<br>50/60 Hz | No difference. |
| | Technical & Functional features comparison: X-Ray emission | | |
| Tube voltage | Panoramic (PAN) and<br>Cephalometric (CEPH) exams: 60 -<br>85 kV - continuous emission<br>CBCT: 90 kV pulsed mode | Panoramic (PAN) and Cephalometric<br>(CEPH) exams: 60 - 85 kV -<br>continuous emission<br>CBCT: 90 kV pulsed mode | No difference. |
| Tube current range | 2 - 16 mA | 2 - 16 mA | No difference. |
| Exposure Time range | 2D: 1s- 18s continuous emission<br>CBCT: 1s -10.4 s pulsed emission | 2D: 1s - 18s continuous emission<br>CBCT: 1s - 10.4 s pulsed emission | No difference. |
| Shape of X-Ray Beam | PAN and CEPH: fan-shaped beam<br>CBCT: cone beam | PAN and CEPH: fan-shaped beam<br>CBCT: cone beam | No significant difference. |
| Focal spot size<br>According IEC 60336 | PAN, CEPH and CBCT: 0.5mm | PAN, CEPH and CBCT: 0.5mm | No difference. |
| Anode Inclination | 10° | 10° | No difference. |
| Collimator | One primary collimator, adjustable<br>in function of selected projection.<br>One secondary collimator for CEPH.<br>Correspondence between X-ray…