Who is the manufacturer of hyperion X5, NewTom GO, X-RADiUS COMPACT?

Cefla S.C. filed the 510(k) submission for hyperion X5, NewTom GO, X-RADiUS COMPACT (K200688).

What is the FDA product code for hyperion X5, NewTom GO, X-RADiUS COMPACT?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for hyperion X5, NewTom GO, X-RADiUS COMPACT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like hyperion X5, NewTom GO, X-RADiUS COMPACT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

hyperion X5, NewTom GO, X-RADiUS COMPACT

K200688 · Cefla S.C. · OAS · Apr 9, 2020 · Radiology

Device Facts

Record ID	K200688
Device Name	hyperion X5, NewTom GO, X-RADiUS COMPACT
Applicant	Cefla S.C.
Product Code	OAS · Radiology
Decision Date	Apr 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, 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: 2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH); 3. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Device Story

Extraoral X-ray system (PAN, CEPH, CBCT) for dental/maxillofacial diagnostics. Device uses rotating arm with X-ray tube and sensors (CMOS for 2D, Amorphous Silicon for 3D) to acquire images. Operated by physicians, dentists, or X-ray technologists in clinical settings. System transforms X-ray projections into 2D panoramic/cephalometric images or 3D tomographic volumes via reconstruction software (NNT/iRYS). Output viewed on PC/tablet; assists clinicians in diagnosing dental/maxillofacial conditions. Benefits include targeted diagnostic imaging with adjustable FOV and reduced radiation exposure compared to full-head systems.

Clinical Evidence

Bench testing included safety/EMC compliance (IEC 60601 series, IEC 60825-1) and performance validation using technical phantoms (QUART DIN 6868-5) to compare spatial resolution, low-contrast resolution, and geometric distortion against predicates. Clinical evidence consisted of comparative evaluations of 2D panoramic, cephalometric, and CBCT images taken on patients/phantoms, demonstrating substantial equivalence in image quality. No formal clinical trial with primary endpoints was required; validation relied on comparative image analysis and end-user feedback.

Technological Characteristics

Extraoral X-ray system; rotating arm with motorized vertical movement. X-ray source: 60-85 kV (PAN/CEPH), 90 kV pulsed (CBCT). Detectors: CMOS (PAN/CEPH), Amorphous Silicon (CBCT) with CsI scintillator. Connectivity: PC/tablet-based GUI. Software: NNT/iRYS for reconstruction/viewing. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-63, 60601-1-6, 62366-1, 62304, 60825-1.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic imaging of the maxillofacial region, including teeth, dental arches, oral cavity structures, cranium parts, and carpus (for cephalometric exams).

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)

Reference Devices

hyperion X5 3D version (K161900)
hyperion X5 2D version (K152162)

Related Devices

K160525 — RCT700 · Ray Co., Ltd. · Jun 20, 2016
K232287 — RAYSCAN a-Expert3D · Ray Co., Ltd. · Aug 31, 2023
K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS · Cefla S.C. · Jan 20, 2022
K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS · Cefla S.C. · Jan 17, 2023
K142247 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Apr 17, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. April 9, 2020 CEFLA S.C. % Lorenzo Bortolotti Regulatory Affairs Via Selice Provinciale 23/A Imola, Bologna 40026 ITALY Re: K200688 Trade/Device Name: hyperion X5, NewTom GO, X-RADiUS COMPACT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: March 9, 2020 Received: March 16, 2020 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200688 Device Name hyperion X5, NewTom GO and X-RADiUS COMPACT Indications for Use (Describe) hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, 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: 2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH); 3. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. 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) #### 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." {3}------------------------------------------------ # hyperion X5 K200688 ### 510(k) Summary #### hyperion X5, NewTom GO and X-RADiUS COMPACT This 510(k) Summary of Safety and Effectiveness information is prepared according to the requirements of 21 CFR Part 807.92. #### 1. General Information | Submitter: | CEFLA S.C. Via Selice Prov.le 23/a Imola, BO 40026 ITALY Tel. +39 0542 653441 Fax +39 0542 653607 | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent Contact: | Lorenzo Bortolotti CEFLA S.C. Via Bicocca 14/c Imola, BO 40026 ITALY Tel. +39 0542 654024 Email: regulatory@cefla.it | | Date 510K summary prepared: | March 9, 2020 | #### 2. Names | Trade/ Device name: | hyperion X5, NewTom GO, X-RADIUS COMPACT | |-----------------------|----------------------------------------------------------------------| | Common or Usual Name: | Extra oral source, Panoramic, Cephalometric, Tomography X-ray system | | Regulatory Name: | Computed tomography X-ray system | | Regulation number: | 21 CFR 892.1750 | | Regulation Class: | Class II | | Product Codes: | OAS | | Subsequent code: | MUH | {4}------------------------------------------------ #### 3. Predicate Devices Proposed device is substantially equivalent to the following legally marketed predicate devices: | Applicant | Device Name | 510(k) Number | Product Code | |------------|-----------------|---------------|--------------| | CEFLA S.C. | hyperion X9 pro | K190496 | OAS MUH | Furthermore, the devices indicated in the table below, already cleared by FDA, has been considered in this submission as reference device. | Applicant | Device Name | 510(k) Number | Product Code | |------------|------------------------|---------------|--------------| | CEFLA S.C. | hyperion X5 3D version | K161900 | OAS MUH | | CEFLA S.C. | hyperion X5 2D version | K152162 | MUH | #### 4. Device Description The proposed device is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement. The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are: | # | Device Name | Brand | manufacturer | |---|------------------|------------|--------------| | 1 | hyperion X5 | myray | CEFLA S.C. | | 2 | NewTom GO | NewTom | CEFLA S.C. | | 3 | X-RADIUS COMPACT | Castellini | CEFLA S.C. | Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT. {5}------------------------------------------------ #### 5. Indications for Use hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to: - produce orthopanoramic images of the maxillofacial region and carry out diagnostic 1. examination on teeth, dental arches and other structures in the oral cavity; - 2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH); - 3. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. #### Comparison of technological characteristics with the predicate and reference devices 6. The proposed device hyperion X5 (PAN, CEPH, CBCT) is a simplified version of the predicate device hyperion X9 pro (K190496), and also a further development of the reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162). Both proposed device and predicate device hyperion X9 pro (K190496), permit the acquisition of panoramic images (PAN), cephalometric images (CEPH) and CBCT images (3D). Compared to hyperion X9 pro (K190496), the proposed device is not intended to create tomographic images of the full head; ear, nose and throat (ENT); other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support. For panoramic acquisitions the proposed device provides similar technological characteristic, operating principles and features of the predicate device hyperion X9 pro (K190496) and the reference devices hyperion X5 2D version (K152162) and hyperion X5 3D version (K161900). The cephalometric acquisitions of hyperion X5 are performed through a CMOS detector, similarly to the predicate device hyperion X9 pro (K190496): the quality of the images acquired by the two devices are substantially equivalent as demonstrated through performance tests. For CBCT image acquisition and 3D processing the proposed device provides the same operating principles and similar technology of hyperion X9 pro device (K190496) and hyperion X5 3D version (K161900). Main Difference: Indication for use: Compared to predicate device hyperion X9 pro (K190496), the proposed device is NOT intend to create tomographic images of the full head, the ear, nose and throat (ENT) and neck with sections of the cervical spine mainly due from the available FOVs and mechanical dimensions. Thus, proposed device is a simplified version of the predicate device. {6}------------------------------------------------ #### hyperion X5 ### CEFLA S.C. 510(K) PREMARKET NOTIFICATION The following cross reference table shows similarity and diversity aspects between the proposed device and the Predicate / Reference devices: | | Proposed Device | Predicate Device | Reference Devices | | | |------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------|-----------------| | Product Name | hyperion X5, NewTom GO, X-RADIUS COMPACT | hyperion X9 pro | hyperion X5 3D version | hyperion X5 2D version | | | Manufacturer | CEFLA S.C. | CEFLA S.C. | CEFLA S.C. | CEFLA S.C. | | | 510(K) No. | - | K190496 | K161900 | K152162 | | | Classification and indications for use | | | | | | | Regulation Number | 892.1750 | 892.1750 | 892.1750 | 872.2100 | | | Regulation Name | Computed tomography x-ray system | Computed tomography x-ray system | Computed tomography x-ray system | Extraoral Source X- Ray System | | | Regulatory Class | Class II | Class II | Class II | Class II | | | Classification Product Code | OAS (Classification Product Code) MUH (Subsequent Product code) | OAS (Classification Product Code) MUH (Subsequent Product code) | OAS (Classification Product Code) MUH (Subsequent Product code) | MUH | | | Indication for use | The hyperion X5 is an | The hyperion X9 pro is | The hyperion X5 | The hyperion X5 | | | | extraoral X-ray system | a digital panoramic, | device, 3D version | device, 2D version | | | | for digital panoramic | cephalometric and | machine, is an image | machine, is an | | | | exams, tele-X-rays and | tomographic extra-oral | reproducer, for | extraoral X-ray | | | | tomographies, | X-ray system, intended | expert professionals, | system for digital | | | | intended to: | to: | intended to: | panoramic X-Rays | | | | (l)produce | | (I)produce | suitable for: | | | | orthopanoramic | (I)produce | orthopanoramic | (l)produce | | | | images of the | orthopanoramic | images of the | orthopanoramic | | | | maxillofacial region | images of the | maxillofacial region | images of the | | | | and carry out | maxillofacial region | and carry out | maxillofacial region, | | | | diagnostic | and carry out | diagnostic | diagnostic | | | | examination on teeth, | diagnostic examination | examination on | examination of the | | | | dental arches and | on teeth, dental arches | teeth, dental arches | dentition (teeth), | | | | other structures in the | and other structures in | and other structures | arches and other | | | | oral cavity; | the oral cavity; | in the oral cavity; | structures of the | | | | (II) produce X-ray | (II) produce | (II) produce | oral cavity. | | | | images of dental | radiographs of jaws, | tomographic images | | | | | arches, cranium parts, | parts of the skull and | of the oral cavity and | | | | | and carpus in support | carpus for the purpose | maxillofacial | | | | | of cephalometric | of cephalometric | structures and carry | | | | | examinations, if | examination, when | out diagnostic | | | | Indication for | equipped with tele-X- | equipped with tele- | examination on | | | | use | ray arm (CEPH); | radiographic arm | teeth, dental arches, | | | | | | (CEPH); | structures of the oral | | | | | (III) produce | (III) produce | cavity and some | | | | | tomographic images | tomographic images | cranial bones. | | | | | of the oral cavity and | of the head, including | The system performs | | | | | maxillofacial | the ear, nose and | tomographic exams | | | | | structures and carry | throat (ENT), of the | with the acquisition | | | | | out diagnostic | dento-maxillo-facial | of X-ray | | | | | examination on teeth, | complex, teeth, | images through a | | | | | dental arches, | mandible and maxilla, | rotating sequence | | | | | structures of the oral | temporomandibular- | and the | | | | | cavity and some | articular joint (TMJ), | reconstruction of a | | | | | cranial bones, if | other areas of the | three-dimensional | | | | | equipped with CBCT | human skull and neck | matrix of the | | | | | option. | with sections of the | examined volume, | | | | | | cervical spine for use | thus producing two- | | | | | The device is | in diagnostic support, | and three | | | | | operated and used by | if equipped with the | dimensional views of | | | | | physicians, dentists, x- | CBCT option. | the volume itself. | | | | | ray technologists and | The device is operated | This technique is | | | | | other legally qualified | and used by | known as CBCT. | | | | | professionals. | physicians, dentists, x- | | | | | | | ray technologists and | | | | | | | other legally qualified | | Page 5 of 10 | | | | | professionals. | | | | | | | Performance features | | | | | Performance specification | Panoramic Cephalometric Computed tomography | Panoramic Cephalometric Computed tomography | Panoramic Computed tomography | Panoramic | | | Patient population | Adult Paediatric | Adult Paediatric | Adult Paediatric | Adult Paediatric | | | Exposition selectable | 2D: PAN, DENT, SIN, TMJ, PAN BITEWING, CEPH 3D: Computed Tomography (CBCT) | 2D: PAN, DENT, SIN, TMJ, PAN BITEWING, CEPH 3D: Computed Tomography (CBCT) | 2D: PAN, DENT, SIN, TMJ, PAN BITEWING 3D: Computed tomography (CBCT) | 2D: PAN, DENT, SIN, TMJ 3D: N/A | | | DAP reduction between Panoramic Standard Child / Panoramic Standard Adult | 0.7 | 0.7 | 0.7 | 0.7 | | | | | Technical & Functional features comparison: (A) X-Ray emission | | | | | Tube voltage | Panoramic (PAN) and Cephalometric (CEPH) exams: 60 - 85 kV - continuous emission CBCT: 90 kV pulsed mode | Panoramic (PAN) and Cephalometric (CEPH) exams: 60 - 85 kV - continuous emission CBCT: 90 kV pulsed mode | PAN: 60 – 85 kV - continuous emission CBCT: 90kV pulsed mode | PAN: 60 - 85 kV - continuous emission | | | Tube current | 4 – 15 mA. | 2 – 16 mA | 4 - 15 mA | 4 – 15 mA | | | Exposure Time | Panoramic (PAN) and Cephalometric (CEPH): 1s - 15s continuous emission | Panoramic (PAN) and Cephalometric (CEPH): 1s - 18s continuous emission | Panoramic: 1s - 15s continuous radiation | Panoramic: 1s - 15s continuous radiation | | | | CBCT: 1 s - 10 s pulsed mode, effective emission time | CBCT: 1s - 10.4 s pulsed emission, effective emission time | CBCT: 6.4 s - 16.8 s pulsed mode, effective emission time | | | | Shape of X-Ray Beam | PAN and CEPH: Fan- shaped beam CBCT: cone beam | PAN and CEPH: Fan- shaped beam CBCT: cone beam | PAN: Fan-shaped beam CBCT: cone beam | PAN: Fan-shaped beam | | | Focal Spot | PAN, CEPH: 0.5, 0.6 mm CBCT: 0.6 mm | PAN, CEPH, CBCT: 0.5 mm | PAN: 0.5 mm, 0.6 mm CBCT: 0.6 mm | PAN: 0.5 mm | | | | | | | | | | Collimator | One primary collimator, adjustable in function of selected projection. One secondary collimator for CEPH. | One primary collimator, adjustable in function of selected projection. One secondary collimator for CEPH. | One collimator, adjustable in function of selected projection. | One collimator, fixed. | | | | FOV | Max 10x10 Min: 6x6 | Max 16x18 Min: 8x6 | Max: 10x10 Min: 6x6 | NA | | | Technical & Functional features comparison: (B) SSD Detector & IMAGE acquisition | | | | | | Image Detector Technology | Panoramic (PAN) and Cephalometric (CEPH) exams: CMOS detector CBCT: Amorphous Silicon PAN and CEPH Image detectors are interchangeable. | Panoramic (PAN) and Cephalometric (CEPH) exams: CMOS detector CBCT: Amorphous Silicon PAN and CEPH Image detectors are interchangeable. | PAN: CMOS detector CBCT: Amorphous Silicon | PAN: CMOS linear detector | | | | Image detectors dimension | PAN:6 x 148 mm CEPH: 6 x 223 mm CBCT: 162 x 162 mm | PAN:6 x 148 mm CEPH: 6 x 223 mm CBCT: 162 x 162 mm | PAN: 6 x 146 mm CBCT:146 x 146 mm | PAN: 6 x 151 mm | | | Detector Pixel size | PAN: 100, 127 μm² CEPH: 100 μm² CBCT: 127 μm² | PAN: 100 μm² CEPH: 100 μm² CBCT: 127 μm² | PAN: 127 μm² CBCT: 127 μm² | PAN: 100 μm² | | PAN (CEPH) Conversion Screen (scintillator) | Csl | Csl | Csl | Csl | | | CBCT Conversion Screen (scintillator) | Csl | Csl | Csl | N/A | | | MTF | 57% @ 1 lp/mm (1x1) | 57% @ 1lp/mm (1x1) | 58% @ 1lp/mm (1x1) | 58% @ 1lp/mm | | | DQE | 70% @ 0 lp/mm (1x1) | 70% @ 0lp/mm (1x1) | 70% @ 0lp/mm (1x1) | 70% @0lp/mm | | | Source to image detector distance (SID) | PAN: 500 mm CEPH: 1610 mm CBCT: 500 mm | PAN: 550 mm CEPH: 1554 mm CBCT: 650 mm | PAN: 500 mm CBCT: 500 mm | PAN: 500 mm | | | Acquisition path | 2 axis – CBCT scan: 210° | 3 axis - CBCT scan: 360° and 210° | 2 axis - 210° | 2 axis - 210° | | | Technical & Functional features comparison: (C) Laser & positioning Number of laser | | | | | | | pointer | 3 | 4 | 3 | 3 | | | Laser optical class | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | | | Number of point of cephalostat | 3 (adjustable) | 3 (adjustable) | 3 (adjustable along X-axis) | 2 (fixed) | | | Technical & Functional features comparison: (D) Control & Viewing Software | | | | | | | Control SW | Firmware (on board) | Firmware (on board) | Firmware (on board) | Firmware + VKB (on PC) | | | Graphical User interface | VKB (on PC or Tablet) | VKB (on board or Tablet or PC) | VKB (on PC or Tablet) | | | | Viewing & reconstruction software | NNT / iRYS | NNT / IRYS | NNT / iRYS | NNT / iRYS (optional) | | | Software validation | IEC 62304 + Guidance FDA on MD SW | IEC 62304 + Guidance FDA on MD SW | IEC 62304 + Guidance FDA on MD SW | IEC 62304 + Guidance FDA on MD SW | | {7}------------------------------------------------ ### CEFLA S.C. 510(K) Premarket Notification {8}------------------------------------------------ ### CEFLA S.C. 510(K) Premarket Notification {9}------------------------------------------------ ### CEFLA S.C. 510(K) Premarket Notification {10}------------------------------------------------ According to the table above, the proposed device has similar technology and features as the predicate device hyperion X9 pro (K190496) and the reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162), pointing out only few differences that have been addressed by dedicated performance tests demonstrating that the proposed device is able to produce images with comparable performances. In conclusion, the different features of proposed system will not affect its classification, working principle, intended use, indications for use and target population and will not rise up new safety and effectiveness questions making proposed system equivalent to predicate device hyperion X9 pro (K190496) and reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162). #### 7. Performance Data The following performance test were executed in support of the substantial equivalence: #### Non-clinical performance data: 1) - A. Safety and EMC test in compliance with: - IEC 60601-1, - IEC 60601-1-2, ● - IEC 60601-1-3, ● - IEC 60601-2-63, - IEC 60601-1-6, - IEC 62366-1, - IEC 62304, - IEC 60825-1. {11}------------------------------------------------ Obtained results demonstrate compliance to the standards listed. - B. Comparison with QUART Technical Phantom (DIN 6868-5) between hyperion X5 and X5 3D version (K161900) for Standard Panoramic X-Rays and between hyperion X5 and hyperion X9 pro (K190496) for the Standard Lateral Ceph X-rays. In both cases, the tested performances are: Spatial resolution and Low contrast resolution. The results obtained demonstrated a substantial equivalence in spatial resolution and in low contrast resolution, both in the comparison of the hyperion X5 with hyperion X5 3D version, and in the comparison between hyperion X5 and hyperion X9 pro. - C. Geometrical comparison performance: The proposed device hyperion X5 (PAN and CEPH projection) was tested in comparison with the reference device hyperion X5 3D version (K161900) and the teleradiograph projections with the predicate device hyperion X9 pro (K190496) using the specific technical phantoms. In the both case, we consider the two devices to be comparable in terms of distortion performance. - D. CBCT geometrical performance: the proposed device was tested using a specific phantom. Obtained results demonstrated that all the measured parameters fall between the acceptance range the same of reference device hyperion X5 3D version (K161900). Hence, that the performances of the proposed device hyperion X5 in terms of noise and geometric distortion are validated. Obtained results demonstrated the substantial equivalence in geometrical performances. - E. The evaluation image quality of the PAN, CEPH and CBCT of hyperion X5, hyperion X9 pro (K190496) and hyperion X5 3D version (K161900). The quality of the evaluation image is performed in two steps. The images obtained with hyperion X5 on anthropomorphic and technical phantom, both in the 2D and 3D case, are compared with the corresponding tests of the reference device hyperion X5 3D version and the predicate device hyperion X9 pro. The performance of the system is validated by performing QA analysis with a suitable cylindrical phantom, with a positive result. It therefore concludes that the verification and validation of images originating from hyperion X5 has a positive outcome. #### 2) Image quality comparison: In addition to the above summarized bench tests, the following comparison of clinical images of Image quality comparison has been performed: {12}------------------------------------------------ - a) Comparative Clinical Evaluation of 2D Panoramic X-rays taken on different hyperion X5 and hyperion X9 pro (K190496); - b) Comparative Clinical Evaluation of CBCT X-ray images taken on the different patient with hyperion X5, hyperion X9 pro (K190496) and hyperion X5 3D version (K161900); - c) Comparative Clinical Evaluation of 2D Panoramic ORTO X-rays taken on the Same Patient with hyperion X5, hyperion X9 pro (K190496); - d) Comparative Clinical Evaluation of Tele-radiography X--rays taken on different patients with hyperion X5 and hyperion X9 pro (K190496); - e) Identification of main marker points of a Quick latero-lateral tele radiography acquired with hyperion X5; - f) On-field Clinical Evaluation of hyperion X5 and end-users feedback report. Obtained results are able to demonstrate the substantial equivalence in performance. Furthermore, the following FDA Guidance documents have been applied: - Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices September 1*, -2016 - Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005 - Content of premarket submissions for Management of Cybersecurity in Medical Devices -October 2, 2014 - Pediatric Information for X-ray Imaging Device Premarket Notifications January 28, 2017 - #### 8. Conclusions In conclusion of the tests summarized above and based on classification, intended use, technological characteristics and performance data, the device proposed with the trade names hyperion X5, NewTom GO and X-RADiUS COMPACT can be found substantially equivalent to the predicated devices hyperion X9 pro (K190496) and reference devices hyperion X5 3D version (K161900), hyperion X5 2D version (K152162).