(57 days)
PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck 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.
PreXion3D Explorer PRO 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 Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
The provided text is a 510(k) Premarket Notification summary for the PreXion3D Explorer PRO, a Computed Tomography X-Ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and does not contain information about the acceptance criteria or a study proving that the device meets specific performance criteria for an AI/CADe/CADx algorithm.
The document details the device's technical specifications, compared to predicate devices, and lists various standards it complies with (e.g., electrical safety, radiation safety, software validation, biocompatibility). It explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
Therefore, based on the provided text, I cannot extract the information required to populate the fields related to acceptance criteria, clinical study design, expert involvement, or AI/software performance metrics (such as MRMC studies, standalone performance, or effect sizes of AI assistance). The device is a hardware imaging system, and its approval is based on equivalence to existing hardware, not on the performance of a novel AI algorithm that requires specific clinical validation metrics.
{0}------------------------------------------------
February 23, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
PreXion Corporation % Mr. Hiroaki Takahashi General Manager 1-14-1 Kandasuda-cho Chiyoda-ku. Tokyo 101-0041 JAPAN
Re: K203784
Trade/Device Name: PreXion3D Explorer PRO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: December 23, 2020 Received: December 28, 2020
Dear Mr. Takahashi:
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) K203784
Device Name PreXion3D Explorer PRO
Indications for Use (Describe)
PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck 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.
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}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Prexion. The logo features the company name in a light gray, sans-serif font, with the "IT" in "make IT visible" in blue. Above the company name is a blue and white swoosh design, adding a modern and dynamic element to the logo.
510(k) Summary
PreXion3D Explorer PRO
K203784
1. Submission Sponsor
PreXion Corporation 1-14-1, Kandasuda-cho, Chiyoda-ku, Tokyo 101-0041 Japan Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division Email: px-ra@prexion.co.jp Office number: +81-3-5297-7037
2. Submission Correspondent
Same as above
3. Date Prepared
December 23th, 2020
4. Device Identification
| Trade/Proprietary Name: | PreXion3D Explorer PRO |
|---|---|
| Common/Usual Name: | OAS: Computed Tomography X-Ray System |
| Regulation Number: | OAS: 21 CFR 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Classification Panel: | Radiology |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a gray sans-serif font. Below the word "Prexion" is the phrase "make IT visible" in a smaller font. Above and to the right of the word "Prexion" is a blue swoosh design.
5. Legally Marketed Predicate Device(s)
Predicate Device (Primary) : K193329, PreXion3D Explorer EX, PreXion Corporation Predicate Device (Seconday) : K190320, PreXion3D Explorer, PreXion Corporation
6. Indication for Use Statement
PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck 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.
7. Device Description
PreXion3D Explorer PRO 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 Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
The operating principle of the device is as follows.
X-rays are generated by the conversion of electron kinetic energy.
Part of the kinetic energy which is generated when electrons moving at high speed are decelerated inside matter becomes the conversion source.
Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's thermal electrons, and then the X-ray will be generated.
The change in the voltage (tube voltage) and current (tube current) applied to the X-ray tube brings the following features.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a light gray, serif font. Below it, in a smaller, red sans-serif font, is the phrase "make IT visible". To the right of the text is a curved, blue graphic that resembles a swoosh or an abstract eye.
- The higher the X-ray tube voltage is, the qreater the penetration strength of X-rays is.
- The higher the current (tube current) is, the more the X-ray dose is.
With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use.
X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm).
The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan).
Cephalometric Exposure .
Based on cephalometric radiography, a plain radiographic image of the properly positioned "patient's head" between X-ray generator and flat panel detector with stable magnification ratio, can be acquired. Also, the image of "patient's hand" can be obtained.
PreXion3D Explorer PRO 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 Explorer PRO 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.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm).
The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
For CT and Panoramic scan, the detected data is reconstructed using filterd-back-projection method. In the case of Cephalometric scan, the acquired 2D data is output as it is.
The software is unchanged from the predicates in terms of function.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Prexion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" portion in a light gray color and the "xion" portion in a darker gray. Below the company name is the tagline "make IT visible" in a smaller font. A blue swoosh design arches over the company name, adding a modern and dynamic element to the logo.
Software Level of Concern -
The software level of concern for the PreXion3D Explorer PRO is Moderate. The rationale is as follows:
Even prior to mitigation of hazards, there is no risk of serious injury or death associated with this software. Excessive X-ray irradiation can be considered as a risk of serious injury, but it is limited in scope by a hardware timer. A hardware activated buzzer indicating exposure and an emergency switch are also provided. As such, there is a risk of injury associated with the software, but not serious injury.
8. Substantial Equivalence Discussion
The following table compares the PreXion3D Explorer PRO to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Subject Device | Predicate Device(Primary) | Predicate Device(Secondary) | |||
|---|---|---|---|---|---|
| Manufacturer | PreXion Corporation | PreXion Corporation | PreXion Corporation | Comparison to Predicate | |
| Trade Name | PreXion3D Explorer PRO | PreXion3D Explorer EX | PreXion3D Explorer | ||
| 510(k) Number | TBD | K193329 | K190320 | N/A | |
| Product Code | OAS | Same | Same | Same | |
| Regulation Number | OAS: 21 CFR 892.1750 | Same | Same | Same | |
| Regulation Name | OAS: Computed tomography x-ray system | Same | Same | Same | |
| Device ClassificationName | X-Ray, Tomography, Computed, Dental | Same | Same | Same | |
| PreXion3D ExplorerPRO is intended toproduce twodimensional digitalpanoramic andcephalometricimages, and three-dimensional digital x-ray images of themaxillofacial, andENT (Ear, Nose andThroat) region at thedirection ofhealthcareprofessionals asdiagnostic support foradult and pediatricpatients.Cephalometricimaging also includesthe hand and wrist to | PreXion3D ExplorerEX is intended toproduce twodimensional digitalpanoramic andcephalometricimages, and three-dimensional digitalx-ray images of themaxillofacial, andENT (Ear, Nose andThroat) region atthe direction ofhealthcareprofessionals asdiagnostic supportfor adult andpediatric patients. | PreXion3D Explorer isintended to producetwo-dimensionaldigital x-ray imagesincluding panoramicand cephalometricimage, and three-dimensional digital x-ray images of thedental, oral,maxillofacialregion,ENT (Ear,Nose and Throat)and neck region atthe direction ofhealthcareprofessionals asdiagnostic support foradult and pediatric | |||
| Indications for use: | obtain carpus imagesfor growth andmaturity assessment.This device is notintended for use onpatients less thanapproximately 21 kg(46 lb) in weight and113 cm (44.5 in) inheight; these heightand weightmeasurementsapproximatelycorrespond to that ofan average 5 year-old. Use ofequipment andexposure settingsdesigned for adults ofaverage size canresult in excessiveradiation exposurefor a smaller patient.Studies have shownthat pediatricpatients may bemore radiosensitivethanadults (i.e., thecancer risk per unitdose of ionizing | This device is notintended for use onpatients less thanapproximately 21kg (46 lb) in weightand 113 cm (44.5in) in height; theseheight and weightmeasurementsapproximatelycorrespond to thatof an average 5year-old. Use ofequipment andexposure settingsdesigned for adultsof average size canresult in excessiveradiation exposurefor a smallerpatient. Studieshave shown thatpediatric patientsmay be moreradiosensitive thanadults (i.e., thecancer risk per unitdose of ionizing | patients.Cephalometricimaging also includesthe hand and wrist toobtain carpus imagesfor growth andmaturity assessment. | Similar | |
| radiation is higher),and so unnecessaryradiation exposure isof particular concernfor pediatric patients. | radiation is higher),and so unnecessaryradiation exposureis of particularconcern forpediatric patients. | ||||
| Patient/User Characteristics | |||||
| Target Population | Children aged 6(except infants) toelderly | Same | Same | Same | |
| Anatomical Site | The dental, oral,maxillofacial regionENT (Ear, Nose andThroat) and neckregion | Same | Same | Same | |
| Users | Health careprofessionals | Same | Same | Same | |
| Technological Characteristics and Performance | |||||
| Patient ContactMaterial | CHIN REST:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber | Same | CHIN REST:polycarbonateHEADREST: carbonBELT: polyvinylchloride | Biocompatibility test resultssupport thatthe materialis safe for theintended use. | |
| Sterility | Non-sterile | Same | Same | Same | |
| TubeVoltage | 90-110KV | 90-110KV | 90-110KV | Same | |
| X-rayGenerati | PulseExposurefunction | Yes | Yes | Yes | Same |
| onDevice | TubeCurrent | 1-5.3mA | 1-5mA | 1-5mA | Same |
| FocalSpot Size | 0.3mm x 0.3mm | Same | Same | Same | |
| Detector | FPD (TFT) | Same | Same | Same | |
| X-rayImageCapturing Device | PixelSize | 248 $μ$ m x248 $μ$ m(With binning)(CT, CT-Panoramic, | 248 $μ$ m x248 $μ$ m(With binning)(CT, CT-Panoramic, | Same | Same assecondarypredicatedevice |
| 124 μm x124μm(Without binning)(CT, CT-Panoramic,Panoramic, Ceph) | 124 μm x124µm(Without binning)(CT, CT-Panoramic,Panoramic)*No Ceph Function | ||||
| 1024x1280(Withbinning)(CT, CT-Panoramic) | 1024x1280(Withbinning)(CT, CT-Panoramic) | 1024x1280(Withbinning)(CT, CT-Panoramic) | RegardingСТ, СТ-Panoramic,all same | ||
| PixelNumber | 2560x2048(Withoutbinning)(CT, CT-Panoramic,Ceph) | 2560x2048(Withoutbinning)(CT, CT-Panoramic)*No Ceph Function | 2560x2048(Withoutbinning)(CT, CT-Panoramic,Ceph) | RegardingCeph, sameas secondarypredicatedevice | |
| 1900 x 120(Panoramic) | 1900 x 120(Panoramic)*No Ceph Function | *No PanoramicFunction | RegardingPanoramicsame asprimarypredicate | ||
| 2112x1754(Cephalometric) | device | ||||
| 253.95mm x317.44mm(CT, CT-Panoramic) | 253.95mm x317.44mm(CT, CT-Panoramic) | 253.95mm x317.44mm(CT, CT-Panoramic) | RegardingСТ, СТ-Panoramic,all same. | ||
| Size ofAreaReceiving X-ray | 230mm x 15mm(Panoramic) | 230mm x 15mm(Panoramic) | *No PanoramicFunction | RegardingPanoramicsame asprimarypredicatedevice | |
| 253.95mm x317.44mm (Ceph) | *No Ceph Function | 253.95mm x317.44mm (Ceph) | RegardingCeph, sameas secondarypredicatedevice | ||
| Numberof Bits | 16bits (CT,Panorama, Ceph) | 16bits (CT,Panorama)*No Ceph Function | Same | Same | |
| SID/SOD | 700mm/ 420mm (CT,CT-Panoramic,Panoramic) | 700mm/ 420mm(CT, CT-Panoramic,Panoramic) | 700mm/ 420mm (CT,CT-Panoramic, Ceph) | Similar | |
| 1000mm / 840mm(Ceph) | *No Ceph Function | ||||
| Scanner | Dimension(WxDxH) | 1164 mm x 1690 mmx 2330 mm (CT, CT-Panoramic,Panoramic, Ceph) | 880 mm x 1267 mmx 2268 mm (CT,CT-Panoramic,Panoramic) | 880 mm x 1267 mmx2268 mm (CT, CT-Panoramic, Ceph) | Similar |
| Weight | 230 kg (CT, CT-Panoramic,Panoramic, Ceph) | 185 kg (CT, CT-Panoramic,Panoramic) | 165 kg (CT, CT-Panoramic, Ceph) | Similar | |
| Imaging Mode | CT scan, CT-Panoramic,Panoramic scan,Cephalometricradiography | CT scan, Panoramicscan,*No Ceph Function | CT scan, CT-Panoramic,Cephalometricradiography | Same assecondarypredicatedevice | |
| Panoramic ScanPerformance (ScanTime) | 8-16sec | 8-16sec | 18sec | Similar | |
| CephalometricRadiography (ScanTime) | 0.16sec | N/A | 0.16sec | Same assecondarypredicatedevice | |
| CT ScanPerformance | ScanTime | 10-20sec | 10-20sec | 10-20sec | Same |
| FOV(VoxelSize) | Diameter 150mm xH156mm (0.100 -0.200mm) | Same | Diameter 150mm xH156mm (0.100 -0.200mm) | Same asprimarypredicatedevice | |
| Diameter 150mm xH100mm (0.100 -0.200mm) | Diameter 150mm xH78mm (0.100 -0.200mm) | ||||
| Diameter 100mm xH100mm (0.100 -0.200mm) | |||||
| Diameter 50mm xH50mm(0.100 - 0.200mm) | Diameter 50mm xH50mm(0.100 - 0.200mm) | ||||
| Applied Standard | |||||
| Electrical SafetyStandard | ANSI/AAMI ES60601-1 | Same | Same | Same | |
| ElectromagneticCompatibilityStandard | IEC 60601-1-2 | Same | Same | Same | |
| Radiation SafetyStandard | IEC 60601-1-3 | Same | Same | Same | |
| Electrical EquipmentUsability SafetyStandard | IEC 60601-1-6 | Same | Same | Same | |
| UsabilityEngineeringStandard | IEC 62366 | Same | Same | Same | |
| Software LifecycleProcess Standard | IEC 62304 | Same | Same | Same |
Table 5A - Comparison of Characteristics
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for PreXion. The logo features the name "PreXion" in a light gray, sans-serif font. Below the name is the tagline "make IT visible" with the "IT" in blue. Above and to the right of the name is a swooping graphic in blue and gray, giving the logo a modern and technological feel.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the "Pre" in a darker gray and the "Xion" in a lighter gray. Below the company name is the tagline "make IT visible" in a smaller font. Above the company name is a blue swoosh design that arches over the text.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a light gray, sans-serif font. Below the word "PreXion" is the phrase "make IT visible" in a smaller font size, with the "IT" in blue. To the right of the text is a stylized graphic element consisting of a blue swoosh with a gray shadow, creating a sense of movement or visibility.
{10}------------------------------------------------
PreXion Corporation Traditional 510(k) Premarket Submission PreXion3D Explorer PRO
Image /page/10/Picture/1 description: The image shows the logo for Prexion. The logo features the word "Prexion" in a stylized font, with the words "make IT visible" underneath in a smaller font. Above the word "Prexion" is a blue and gray swoosh design, which gives the logo a modern and dynamic look.
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a light gray, sans-serif font. Below the name is the tagline "make IT visible" in a smaller font. Above and to the right of the name is a blue and gray swoosh design.
| Essentialperformance ofdental extra-oral X-ray equipmentStandard | IEC 60601-2-63 | |
|---|---|---|
| Acceptance tests ofImagingperformance ofdental X-rayequipment Standard | IEC 61223-3-4 | |
| Acceptance tests ofImagingperformance ofcomputedtomography X-rayequipment Standard | IEC 61223-3-5 | |
| Laser SafetyStandard | IEC 60825-1 | |
| Risk ManagementStandard | ISO 14971 | |
| DICOM Standard | NEMA PS 3.1 - 3.20 | |
| BiocompatibilityStandardCompliance | ISO 10993-1 | |
| BiocompatibilityStandardCompliance | ISO 10993-5 | |
| BiocompatibilityStandardCompliance | ISO 10993-10 |
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of PreXion3D Explorer PRO and in showing substantial equivalence to the predicate device, PreXion completed a number of nonclinical performance tests. The PreXion3D Explorer PRO meets all the requirements for overall design, biocompatibility, performance, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The PreXion3D Explorer PRO passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
- . Electrical safety testing per ANSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the logo for Prexion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" in a darker gray and the "Xion" in a lighter gray. Below the company name is the tagline "make IT visible" in a smaller font. Above and behind the company name is a curved, swooping graphic in shades of blue and gray, adding a dynamic element to the logo.
- . Dental extra-oral X-ray equipment testing per IEC 60601-2-63
- Software verification and validation IEC 62304 ●
- . Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5
- Storage and Transport Testing per ISO 4180 .
- . IEC 62366-1:2015 Usability engineering to medical devices
- . Software Documentation per: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . Establish the substantial equivalence of an SSXI to a previously cleared conventional radiographic SSXI per: "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
- . Cybersecurity Activities per: "Cybersecurity-for-Networked-Medical-Devices-Containing-Offthe-Shelf-(OTS)-Software---Guidance-for-Industry", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
10.Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
The PreXon3D Explorer PRO, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.
§ 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.