(87 days)
PreXion3D Excelsior is intended to produce two dimensional digital panoranic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
Cephalometric imaging also includes the hand wrist to obtain carpus innages for growth and maturity assessment.
PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
The provided text describes the PreXion3D Excelsior, a dental cone-beam computed tomography device, and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those specified acceptance criteria in the way requested by your prompt.
Specifically, the document states:
- Non-clinical performance data: Conformance to harmonized standards (listed in section 5.7), testing for 3D imaging performance to assess MTF (Modulation Transfer Function) for three image orientations (x, y, z) for 3D modes, and non-clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."
- Clinical performance data: Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" were performed by qualified clinical assessors.
However, the document lacks specific quantitative acceptance criteria (e.g., minimum MTF values, specific accuracy thresholds for diagnostic tasks) and detailed results from a study that would demonstrate the device met those specific criteria. The evaluation focuses on substantial equivalence based on conformance to standards and general considerations rather than a detailed performance study with defined acceptance criteria and statistical analysis.
Therefore, I cannot populate the table and answer the following questions with the provided text:
- A table of acceptance criteria and the reported device performance: The document lists standards it conforms to but does not quantify specific acceptance criteria (e.g., for image quality, diagnostic accuracy) with corresponding performance values.
- Sample sizes used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. It mentions "qualified clinical assessors" for clinical considerations but no further detail.
- Adjudication method: Not specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance study: Not mentioned. The device is a hardware imaging system, not an AI algorithm in the typical sense for standalone performance.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not applicable as this is a hardware device submission, not an AI algorithm requiring a training set in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence based on technological characteristics and general safety/effectiveness considerations, not to provide a detailed performance study against specific, quantified acceptance criteria for a novel diagnostic algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design formed by three overlapping profiles of human faces. The faces are oriented to the right and are stacked on top of each other. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2016
PreXion Corporation % Mr. Shumpeita Torii Director Funai Tokyo Technology Center Building. 1-14-1 Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN
Re: K161881
Trade/Device Name: PreXion3D Excelsior Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 8, 2016 Received: September 9, 2016
Dear Mr. Torii:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161881
Device Name PreXion3D Excelsior
Indications for Use (Describe)
PreXion3D Excelsior is intended to produce two dimensional digital panoranic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
Cephalometric imaging also includes the hand wrist to obtain carpus innages for growth and maturity assessment.
Type of Use (Select one or both, as applicable)
2 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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
510(k) Number: K161881
5.1 Applicant Information
| Date Prepared: | Sep. 8th, 2016 |
|---|---|
| Company Name and Address: | PreXion CorporationFunai Tokyo technology center building,1-14-1 Kandasuda-cho, Chiyoda-kuTokyo, 101-0041Japan |
| Contact Person: | Mr. Shumpeita ToriiDirector, Quality Assurance and Regulatory DivisionPhone: +81-3-5297-7551FAX: +81-3-5297-7552Email: torii@prexion.co.jp |
5.2 Device Information
| Device Type: | Dental Cone-beam Computed Tomography |
|---|---|
| Regulation Description: | Computed Tomography X-Ray System |
| Review Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1750 |
| Product Code: | OAS |
| Device Class: | II |
| Device Name: | Prexion3D Excelsior |
5.3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| 510(k) Number: | K122199 | K103659 | K133620 |
|---|---|---|---|
| Applicant: | THE YOSHIDADENTAL MFG. CO.,LTD. | Trophy | Imaging SciencesInternational, LLC |
| Device Name: | PREXION 3DECLIPSE | CS 9300 and CS9300C | i-CAT FLX Cone Beam3D and 2D PanoramicDental Imaging System |
| Regulation Number: | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Product Code: | OAS | OAS | OAS |
| Device Class: | II | II | II |
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5.4 Device Description
PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
5.5 Intended Use/Indications for Use
PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
5.6 Technological Characteristics
The subject device compares to the legally marketed devices as follows:
| Subject Device | Predicate device | |||
|---|---|---|---|---|
| PreXion3DExcelsior | PREXION 3DECLIPSE(K122199) | CS 9300 and CS9300C(K103659) | i-CAT FLX ConeBeam 3D and 2DPanoramicDental ImagingSystem(K133620) | |
| Device | ||||
| IntendedUse/Indicationsfor Use | PreXion3DExcelsior isintended toproduce twodimensional digitalpanoramic andcephalometricimages, and threedimensional digitalx-ray images ofthe maxillofacial,and ENT (Ear,Nose and Throat)region at the | PREXION3DECLIPSE isintended toproduce two-dimensional digitalpanoramic andcephalometricimages, and three-dimensional digitalx-ray images ofthe dento-maxillo-facial region at thedirection ofhealthcare | The CS 9300 andCS 9300C aresystems intendedto produce two-dimensional andthree-dimensionaldigital x-rayimages of thedento-maxillo-facial, and ENT(Ear, Nose andThroat) regions atthe direction ofhealthcare | Devices of the i-CAT family consistof an x-ray systemthat uses a conebeam with arotationalsequence,providing twodimensionalimages and threedimensionalvolumereconstructions ofthe head area, |
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| Device | Subject Device | PreXion3DExcelsior | PREXION 3DECLIPSE(K122199) | Predicate device | CS 9300 and CS9300C(K103659) | i-CAT FLX ConeBeam 3D and 2DPanoramicDental ImagingSystem(K133620) |
|---|---|---|---|---|---|---|
| direction ofhealthcareprofessionals asdiagnostic supportfor adult andpediatric patients.Cephalometricimaging alsoincludes the handand wrist to obtaincarpus images forgrowth andmaturityassessment. | professionals asdiagnosticsupport. | professionals asdiagnostic supportfor pediatric andadult patients.In addition, the CS9300C is intendedto producecephalometricimages. Thisincludes imagingthe hand and wristto obtain thecarpus image forgrowth andmaturityassessment. | which includesENT andmaxillofacial areas(such as TM Jointstudies, mandible& maxilla forimplant planning,sinuses), for usein planning anddiagnostic supportin adult andpediatric care.Devices of the i-CAT familycomprise apackage ofsoftware modulescapable ofhandling 2D and3D data. Thisincludes 3Dreconstruction,storage, retrieval,viewing, andprocessing of 2Dand 3D-imagedata. | |||
| X-rayGenerationDevice | TubeVoltage | 60-110KV | 50-90 kV | 60 - 90 kV | 84-120 kV94 kV (Panoramic)84 kV (Panoramicsmall) | |
| PulseExposurefunction | Yes | N/A | Yes | Yes | ||
| TubeCurrent | 1-6mA | 2.6-4 mA | 2 - 15 mA | 3-7mA5mA (Panoramicand Panoramicsmall) | ||
| FocalSpotSize | 0.3mm | 0.2 mm | 0.7 mm | 0.5mm | ||
| X-rayImage | Detector | FPD (TFT) | FPD (CMOS) | FPD (TFT) | FPD (TFT) | |
| PixelSize | 125 μm | 200 μm (CT) | 127 μm | 127um x 127um | ||
| Device | Subject Device | PreXion3D Excelsior | PREXION 3D ECLIPSE (K122199) | Predicate device CS 9300 and CS 9300C (K103659) | i-CAT FLX Cone Beam 3D and 2D Panoramic Dental Imaging System (K133620) | |
| uring Devic e | x250μm(CT)125 μm x 125μm(Panoramic )140 μm x 140μm (Ceph) | 100 μm (Panoramic)54 μm (Ceph) | ||||
| Pixel Number | 1280x1024 (CT)100x1280 (Panoramic)2112x1754 (Cephalometric) | 640x656 (CT)80x1312 (Panoramic)128x4080 (Ceph) | 64 x 1536 (Panoramic) | 1536 x 1920768 x 960 | ||
| Size of Area Receiving X-ray | 160mm x 128mm (CT)160mm x 12.5mm (Panoramic)295.68 x 245.56mm (Ceph) | 128.1 mm x 131.3 mm (CT)8 mm x 131.3 mm (Panoramic)6.9 mm x 312 mm (Ceph) | 5 x 149 mm max (Panoramic) | 242mm x 192mm (CT)10mm x 100mm (Panoramic) | ||
| Number of Bits | 16bits (CT, Panorama)14bits (Ceph) | 14 bits (CT, Panoramic)16 bits (Ceph) | 14 Bits | 16 bits | ||
| SID/SOD | 700mm/ 470mm (CT, Panoramic)1650mm / 1500mm (Ceph) | 620 mm / 400 mm (CT, Panoramic)1650 mm / 1500 mm (Ceph) | 615 mm (SID) | 714mm / 495mm | ||
| Scan ner | Dimension (WxDxH) | 930 mm x 1230 mm x 2220 mm (CT, Panoramic)1747 mm x 1230 mm x 2220 mm (with Ceph) | 1245 mm x 1288 mm x 2045 mm (CT, Panoramic)1805 mm x 1288 mm x 2045 mm (Ceph) | 1158 mm x 1595 mm x 2378 mm | 1222mm x 1340mm x 1820mm | |
| Device | Subject DevicePreXion3DExcelsior | PREXION 3DECLIPSE(K122199) | Predicate deviceCS 9300 and CS9300C(K103659) | i-CAT FLX ConeBeam 3D and 2DPanoramicDental ImagingSystem(K133620) | ||
| Weight | 165 kg (CT,Panoramic)200kg (Ceph) | 260 kg (CT,Panoramic)300 kg (Ceph) | 160 kg (CT,Panoramic)190 kg (Ceph) | 231kg | ||
| Imaging Mode | CT scan,Panoramic scan,Cephalometricradiography | CT scan,Panoramic scan,Cephalometricradiography | CT scan,Panoramic scan,Cephalometricradiography | CT scan,Panoramic scan | ||
| PanoramicScanPerformance(Scan Time) | 4-16sec | Standard mode:16 sec | 4 - 16 sec | 18.3 -20.0 sec | ||
| CephalometricRadiography(Scan Time) | 0.5-0.8 sec | LA, PA, Carpus:8, 10, 12, 15 sec | 0.1 - 3.2 sec | N/A | ||
| CTScanPerformance | ScanTime | 6.9-25.6sec | Light mode: 8.7secHigh Definitionmode: 8.7 secUltra HighDefinition mode:17.4 secWide mode: 9.1sec x 2 | 12 - 20 sec28 sec | 4.8 - 26.9 sec | |
| FOV(VoxelSize) | Diameter 100mmx H76mm(0.100 - 0.200mm)Diameter 150mmx H75 (0.200mm)Diameter 100mmx H50mm(0.100 - 0.200mm)Diameter 50mm xH50mm(0.100 - 0.200mm) | Light mode, HighDefinition mode,Ultra HighDefinition mode:Diameter 81 mm,H 75 mmWide Mode:Diameter 113 mm,H 72 mm | Diameter 170 mm/H135 mm (0.090mm - 0.500 mm)Diameter 170 mm/H110 mm (0.090mm - 0.500 mm)Diameter 170 mm/H60 mm (0.090mm - 0.500 mm)Diameter 100 mm/H100 mm (0.090mm - 0.500 mm) | Diameter x Height8 cm x 8 cm16 cm x 4 cm16 cm x 6 cm16 cm x 8 cm16 cm x 10 cm16 cm x 11 cm16 cm x 13 cm23 cm x 17 cm(3D ceph)Voxel size: 0.125,0.2, 0.25, 0.3,0.4mm |
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| Subject Device | Predicate device | ||||
|---|---|---|---|---|---|
| Device | PreXion3DExcelsior | PREXION 3DECLIPSE(K122199) | CS 9300 and CS9300C(K103659) | i-CAT FLX ConeBeam 3D and 2DPanoramicDental ImagingSystem(K133620) | |
| Volume Size | 512x512x5121024x1024x800 | 512x512x512 | 250 x 250 x 250267 x 267 x 267339 x 339 x 220567 x 567 x 367-450850 x 850 x 300 | 320x320x288536x536x443768x768x288 | |
| Dose Level(CTDIw) | Standard (110KV,3.3mA, 12.8s)10cm: 2.9mGy5cm: 1.9mGyRapid (110KV,2.1mA, 6.9s)10cm: 0.9mGy5cm: 0.8mGyHigh Resolution(110KV, 3.6mA,25.6s)10cm: 4.9mGy5cm: 3.2mGyHigh Contrast(110KV, 2.1mA,25.6s)10cm: 8.7mGy5cm: 5.7mGyStandard Child(95KV, 2.2mA,12.8s)10cm: 1.4mGy5cm: 1.0mGyRapid Child | High Definition(90KV, 4mA, 8.7s)8cm: 4.57mGyUltra HighDefinition (90KV,4mA, 17.4s)8cm: 9.32mGyWide (90KV, 4mA,9.1s x 2)11cm: 6.67mGyLight (90KV,2.6mA, 8.7s)8cm: 3.01mGy | 90KV, 6.3mA,12sec, 8cm x 8cm:4.31mGy90KV, 6.3mA,12sec, 5cm x 5cm:3.70mGy90KV, 6.3mA,20sec, 5cm x 5cm:6.46mGy | 3D Ceph (120KV,5mA, 8.9s)13cm: 1.9mGy*,11cm: 1.9mGy*,10cm: 1.9mGy*,8cm: 2.0mGy*,6cm: 2.0mGy*,4cm: 2.1mGy*Quick Scan(120KV, 5mA,4.8s)13cm: 1.0mGy*,11cm: 1.0mGy*,10cm: 1.0mGy*,8cm: 1.0mGy*,6cm: 1.0mGy*,4cm 1.6mGy*:Quick Scan+(90KV, 3mA, 4.8s)13cm: 0.3mGy*,11cm: 0.3mGy*,10cm: 0.3mGy*,8cm: 0.3mGy*,6cm: 0.3mGy*,4cm: 0.3mGy*HD (120KV, 5mA, | |
| Subject Device | Predicate device | ||||
| Device | PreXion3DExcelsior | PREXION 3DECLIPSE(K122199) | CS 9300 and CS9300C(K103659) | i-CAT FLX ConeBeam 3D and 2DPanoramicDental ImagingSystem(K133620) | |
| (95KV, 1.6mA,6.9s)10cm: 0.5mGy5cm: 0.4mGy | 26.9s)13cm: 3.8mGy*,11cm: 3.9mGy*,10cm: 3.6mGy*,8cm: 4.0mGy*,6cm: 4.0mGy*,4cm: 4.2mGy*Quick Scan HD(120KV, 5mA,14.7s)13cm: 2.1mGy*,11cm: 2.1mGy*,10cm: 2.0mGy*,8cm: 2.1mGy*,6cm: 2.1mGy*,4cm: 2.2mGy** the sum of1/3 of the phantomcentral dose and2/3 of theperipheral dose. | ||||
| PerformanceStandards | ANSI/AAMIES60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 62366IEC 62304IEC 60601-2-63IEC 61223-3-4IEC 61223-3-5IEC 60825-1ISO 14971NEMA PS 3.1 -3.20ISO 10993-1ISO 10993-5ISO 10993-10 | UL 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60825-1IEC 61233-3-4IEC 61223-3-5IEC 62304ISO 14971NEMA PS 3.1 -3.20 | Unknown | IEC 60601-1:2005IEC 60601-1-6:2010IEC 62366:2007IEC 60601-2-63:2012IEC 60601-1-2:2007ISO 10993-5ISO 10993-10 |
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5.7 Non-Clinical Performance Data
The subject device has demonstrated conformance to non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:
ANSI/AAMI ES60601-1 IEC 60601-1-2 IEC 60601-1-3 IEC 60601-1-6 IEC 62366 IEC 62304 IEC 60601-2-63 IEC 61223-3-4 IEC 61223-3-5 IEC 60825-1 ISO 14971 NEMA PS 3.1 - 3.20 ISO 10993-1 ISO 10993-5 ISO 10993-10
In addition to the conformance with the above recognized standards, the following testing and nonclinical considerations were preformed:
- . Testing for 3D imaging performance to assess MTF for three image orientations (x, y, z) for the applicable 3D modes of device operation.
- . Non-clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
Results of all non-clinical testing and non-clinical considerations support the safety and effectiveness of the subject device.
5.8 Clinical Performance Data
Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" were performed by the qualified clinical assessors. Results of the clinical consideration support the safety and effectiveness of the subject device.
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5.9 Conclusions
The subject device has the same intended use/Indications for use as the predicate devices. The subject and predicate devices also share similar technological characteristics such as specifications of X-ray Generation Device. X-ray Image Capturing Device and Scanner. Imaging Mode (i-CAT does not have a Cephalometric imaging mode), Scan Mode and conformance with Performance Standards. The subject and predicate devices also have differences in technological characteristics, such as Tube Voltage, Pulse Exposure, Tube Current, Focal Spot Size, Pixel Number, Size of Area Receiving X-ray, Detector, Number of Bits, Scanner SID/SOD, Panoramic Scan Performance (Scan Time), Cephalometric Radiography (Scan Time), CT Scan Time, FOV (Voxel Size), Volume Size, Dose Level (CTDIw) and Performance Standards.
We conducted non-clinical and clinical performance testing as follows:
- Conformance with the harmonized standards .
- Testing for 3D imaging performance to assess MTF for the three image orientations .
- . Non-clinical and Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance data and clinical performance data demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.