(259 days)
The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The Veraview X800 has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
Here's a breakdown of the acceptance criteria and study information for the J.Morita USA, Inc. Veraview X800, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Device Performance (Veraview X800) |
|---|---|---|
| Panoramic - spatial resolution | Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm | Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm |
| Panoramic - noise | Low contrast resolution on IEC 61223-3-4: min. diameter 2.0 mm (at High speed mode) | Low contrast resolution on IEC 61223-3-4: min. diameter 2.0 mm (at High speed mode) |
| Low contrast resolution on IEC 61223-3-4: min. diameter 1.0 mm (at High resolution mode) | Low contrast resolution on IEC 61223-3-4: min. diameter 1.0 mm (at High resolution mode) | |
| Cephalometric - spatial resolution | Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm | Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm |
| Cephalometric - noise | Low contrast resolution on IEC 61223-3-4: min. diameter 2.5 mm | Low contrast resolution on IEC 61223-3-4: min. diameter 2.5 mm |
| CBCT - spatial resolution | min. 10% MTF at 2.0 LP/mm (at standard mode) | min. 10% MTF at 2.0 LP/mm (at standard mode) |
| min. 10% MTF at 2.5 LP/mm (at high resolution mode) | min. 10% MTF at 2.5 LP/mm (at high resolution mode) | |
| CBCT - noise | The standard deviation of the gray scale of the center region of the Contrast phantom shall be less than 12.5 (10% of the full scale). | The standard deviation of the gray scale of the center region of the Contrast phantom shall be less than 12.5 (10% of the full scale). |
| System MTF (FOV 4x4 High Resolution) | 2.25 lp/mm @10% (Predicate FOV 5x5 High Resolution) | 2.5 lp/mm @10% (FOV 4x4 High Resolution) |
| CMOS flat panel pixel size | 100 μm x 100 μm (Predicate) | 0.1 mm x 0.1 mm |
| Effective exposure time (CBCT) | 1.2 - 12.5 s (Primary Predicate) / 1.7 - 20 s (Reference Predicate) | Scout: 0.5, 1.0 s; CBCT: 9.4, 17.9 s; 17.9 x 2 for FOV 15 x 14 |
| CBCT Reconstruction Time | 1-3 min. (Predicates) | 1-6 min. (depending on the computer specification) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that non-clinical testing was conducted. This typically refers to physical phantom testing and bench testing rather than testing on a "test set" of patient data. Therefore, information about patient data sample size or provenance is not applicable/provided in this 510(k) summary for the performance verification. The data provenance would be from laboratory or manufacturing testing environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since the testing was non-clinical and involved phantom measurements and compliance with standards, there are no experts mentioned as establishing ground truth for a patient test set. The ground truth is inherent in the physical phantoms and the established scientific principles of the standards (e.g., IEC 61223-3-4).
4. Adjudication Method for the Test Set:
Not applicable, as no patient-based "test set" requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states: "There were no clinical tests performed for Veraview X800." Therefore, an MRMC study using human readers was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is an X-ray imaging system, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm performance" study is not applicable in the context of this 510(k) summary. The performance metrics evaluated are for the image acquisition and reconstruction capabilities of the device itself.
7. The Type of Ground Truth Used:
The ground truth used for the performance evaluation was established through recognized international standards and physical phantom measurements. For example:
- Spatial Resolution: Measured using line pair phantoms as per IEC 61223-3-4.
- Noise and Low Contrast Resolution: Measured using contrast phantoms as per IEC 61223-3-4.
- MTF (Modulation Transfer Function): Measured using standardized methods to assess the system's ability to transfer contrast at different spatial frequencies.
8. The Sample Size for the Training Set:
This device is a hardware X-ray system that produces images. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense for image interpretation. Therefore, information about a training set sample size is not applicable/provided.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set discussed for an AI/ML algorithm.
{0}------------------------------------------------
December 19, 2017
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.
J.Morita USA, Inc. % Keith Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005
Re: K171012
Trade/Device Name: Veraview X800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: March 30, 2017 Received: April 4, 2017
Dear Keith Barritt:
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 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);
{1}------------------------------------------------
Page 2 - Keith Barritt
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K#171012
Device Name Veraview X800 X-Ray System
Indications for Use (Describe)
The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
Type of Use (Select one or both, as applicable)
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}------------------------------------------------
510(k) Summary J. Morita USA Inc. Veraview X800 X-ray system for Panoramic, Cephalometric and CBCT imaging
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date
(i) 510(k) Submitter
Registration No. 2081055 J. Morita USA, Inc. 9 Mason, Irvine, CA 92618, USA Phone: 949-581-9600 Fax: 949-581-9688
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington DC 20005, USA Phone: (202) 783-5070 Fax: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
December 14, 2017
807.92(a)(2): Name of Device
| Trade or Proprietary Name: | Veraview X800 |
|---|---|
| Model Name: | X800 |
| Common Name: | Dental Computed Tomography X-ray System imaging |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
{4}------------------------------------------------
807.92(a)(3): Predicate Device
The Veraview X800 is substantially equivalent for purposes of FDA medical device regulations to the following primary predicate device:
| Trade or Proprietary Name: | OP300 (K#133544) |
|---|---|
| Common Name: | Dental panoramic cephalometric and cone beam computedtomography x-ray device |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
K#170813 is a secondary/reference predicate device:
| Trade or Proprietary Name: | ORTHOPANTOMOGRAPH™ OP 3D (K#170813) |
|---|---|
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
- J. MORITA CORP.'s own X550 (K#073696) is a secondary/reference predicate device:
| Common Name: | Dental Panoramic/Cephalometric X-ray System with CTCapability | |
|---|---|---|
| Classification Name: | Extra-oral source dental x-ray system | |
| Device Classification Panel: | Class II, Radiology | |
| Product Code: | MUH | |
| Regulation: | 21 CFR 872.1800 |
807.92(a)(4): Device Description
The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The Veraview X800 has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
{5}------------------------------------------------
807.92(a)(5): Intended Use
The intended use of the X800 is:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- Cone beam computed tomography -
The intended use of the primary predicate device is:
The OP300 dental panoramic, cephalometric and cone beam computed tomography x-rav device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
Indication for Use
Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
807.92(a)(6): Technological Characteristics
Comparison tables of the Veraview X800 and (1) the primary predicate K#133544 and reference device K#170813 and (2) the reference device K#073696 appear below:
{6}------------------------------------------------
| Proposed device | Primary predicate device (ORTHOPANTOMOGRAPH™ OP300, K133544) | Reference predicate device (ORTHOPANTOMOGRAPH™ OP 3D, K170813) | |
|---|---|---|---|
| 1Indications for Use/Intended Use | Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients | The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. | ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the craniomaxillofacial complex for use in diagnostic support. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals |
Comparison table for the primary predicate K133544 and reference K#170813 devices:
{7}------------------------------------------------
| Proposed device | Primary predicatedevice(ORTHOPANTOMOGRAPH™ OP300,K133544) | Reference predicate device(ORTHOPANTOMOGRAPH™OP 3D, K170813) | ||
|---|---|---|---|---|
| 2 | Imagingmodes | PanoramicCBCTCephalometric | PanoramicCBCTCephalometric | PanoramicCBCT |
| 3 | Focal spot | 0.5 | 0.5 | 0.5 |
| 4 | Imagedetector | CMOS Flat Panel +CCDdetector(ceph) | CMOS Flat Panel+CMOS detector(Pan/ceph) | CMOS Flat Panel |
| 5 | CBCTimagingtechnique | Reconstruction from 2Dimages | Reconstruction from2D images | Reconstruction from 2D images |
| 6 | CBCT'sField OfView(cm) | 4 x 48 x 4, 5, 810 x 4, 5, 815 x 5, 7.5, 14 | 5x56x88x88x1513x15 | 5 x 56 x 99 x 119 x 14 |
| 7 | CBCT'stotalviewingangle | 180, 360 degree | 360 degree | 360 degree |
| 8 | CBCT'seffectiveexposuretime (s) | Scout: 0.5, 1.0CBCT: 9.4, 17.917.9 x 2 for FOV 15 x 14 | 1.2 - 12.5 | 1.7 - 20 |
| 9 | CBCTReconstructionTime | 1-6 min. (depending onthe computerspecification) | 1-3 min. | 1-3 min. |
| 10 | Patient'sPosition | Standing and wheelchair | Standing andwheelchair | Standing and wheelchair |
| 11 | Systemfootprint(includestheoperator) | H218.5-232.5cm D120cmW140-200 cm | H161-241cmD139cmW97-193 cm | H167-247cmD77-100cm130 cm |
| 12 | Weight | Pan/CBCT 185-190 kgCeph 220-225 kg | Pan/CBCT 205 kgCeph 240 kg | 100 kg |
| 13 | Classification | OAS | OAS | OAS |
| 14 | CBCTresolution | Standard, high resolution | Low , standard, high,endo | Low , standard, high, endo |
| Proposed device | Primary predicate device(ORTHOPANTOMOGRAPHTM OP300,K133544) | Reference predicate device(ORTHOPANTOMOGRAPHTMOP 3D, K170813) | ||
| 15 | 2Dimagingprograms | Adult Pan, Child Pan,TMJ, BW, Partial Pan | Adult Pan, Child Pan,TMJ, BW,Partial Pan | Adult Pan, Child Pan, TMJ, BW,Partial Pan |
| 16 | - | - | - | - |
| 17 | CMOS flatpanel pixelsize | 0.1 mm x 0.1 mm | 100 μm x 100 μm | 99 μm x 99 μm |
| 18 | SystemMTF | 2.5 lp/mm @10%FOV 4x4High Resolution | 2.25 lp/mm @10%FOV 5x5High Resolution | 2.2 lp/mm@10%FOV 5x5High Resolution |
{8}------------------------------------------------
{9}------------------------------------------------
Comparison table for the reference predicate K#073696 is as follows:
| Item | Device submitted in this 510(k) | Reference device | Loading factors | Tube Potential: 60-100kVTube Current: 2-10mALoading time: max. 18.5s | Tube Potential: 60-90kVTube Current: 1-10mALoading time: max. 20.3s | |
|---|---|---|---|---|---|---|
| Product name | Veraview X800 | Veraviewepocs | Design | X-ray tubeassembly | Nominal focal spot: 0.5 at targetangleInherent filtration min. 2.5mmAL | Nominal focal spot: 0.5 at targetangleInherent filtration min.2.5mmAL |
| Model | X800 | X550 | X-ray detector 1 | Internal parts code: D001-15038-50*See column in predicate device. | Internal parts code: D001-15038-50*CMOS flat panelScintillator: CsIPixel size for Pan: 0.1 mmPixel size for CBCT: 0.1 mm,0.2 mm | |
| Manufacturer | J. MORITA MFG. CORP. | J. MORITA MFG. CORP. | X-ray detector 2 | Internal parts code: D001-16044-50*CMOS flat panelScintillator: CsIPixel size for Pan: 0.1 mmPixel size for CBCT: 0.1 mm,0.2 mm | Internal parts code: D00-113030-50*CMOS flat panelScintillator: CsIPixel size for Pan and CBCT:0.2 mm | |
| Indications for use | Veraview X800 is intended to beused for panoramic tomographyincluding linear tomography andscanogram, cephalometricradiography, and cone beamcomputed tomography.Veraview X800 is an extraoralsource X-ray unit that is used fordental and head radiographicexamination and diagnosis ofteeth, jaw, oral structure,temporomandibular joint, skullincluding the dento-maxillofacialareas, and hand for maturityassessment, by exposing an X-rayimage receptor to ionizingradiation.The device uses a cone shaped X-ray beam projected on to a flatpanel detector, and the examinedvolume image is reconstructed tobe viewed in 2D or 3D viewingstations.The device is to be operated andused by dentists and other legallyqualified professionals forpediatric and adult patients. | The Veraviewepocs is anextraoral source X-ray unit thatis used for dental radiographicexamination and diagnosis ofteeth, jaw, oral structure, TM-joints and skull including theENT and dento-maxillofacialareas, by exposing an X-rayimage receptor to ionizingradiation.The device uses cone shaped X-ray beam projected on to a flatpanel detector, and the examinedvolume image is reconstructed tobe viewed in 2D or 3D viewingstations.The device is to be operated andused by dentists and otherlegally qualified professionals. | X-ray detector 3 | Internal parts code: D001-04188-50*See column in predicate device. | Internal parts code: D001-04188-50*CCD line sensorScintillator: CsIPixel size for Ceph: 0.1 mm | |
| Energy used and/ordelivered | AC 120 V, 60 Hz | AC 120 V, 60 Hz | Soft-ware | Viewer(general purposeviewer: notincluded in thissubmission ofthe device) | Viewer software:510K number: K073704Device name: i-Dixel |
{10}------------------------------------------------
{11}------------------------------------------------
| Panoramic- spatialresolution | Line pair resolution on IEC61223-3-4: min. 2.5 LP/mm | Line pair resolution: min. 2.5LP/mm | |
|---|---|---|---|
| Perfor | Panoramic- noise | Low contrast resolution on IEC61223-3-4: min. diameter 2.0 mmat High speed mode, min.diameter 1.0 mm at Highresolution mode | Low contrast resolution on IEC61223-3-4: min. diameter 2.0mm |
| mance | Cephalometric- spatialresolution | Line pair resolution on IEC61223-3-4: min. 2.5 LP/mm | |
| Cephalometric- noise | Low contrast resolution on IEC61223-3-4: min. diameter 2.5 mm | Low contrast resolution on IEC61223-3-4: min. diameter 2.5mm | |
| CBCT- spatialresolution | min. 10% MTF at 2.0 LP/mm atstandard modemin. 10% MTF at 2.5 LP/mm athigh resolution mode | min. 10% MTF at 2.0 LP/mm | |
| CBCT- noise | The standard deviation of the grayscale of the center region of theContrast phantom shall be lessthan 12.5 (10% of the full scale). | The standard deviation of the grayscale of the center region of theContrast phantom shall beless than 12.5 (10% of the fullscale). |
807.92(b)(l): Non-clinical Testing
The Veraview X800 has been tested for compliance and developed in accordance with the following international standards:
| IEC/ISO Standard | FDA Recognition number |
|---|---|
| IEC 60601-1:2005+A.MD1:2012 | 19-4 |
| IEC 60601-1-2:2007 | 19-1 |
| IEC 60601-1-3:2008+AMD1: 2013 | 12-269 |
| IEC 60601-1-6:2010+AMD1:2013 | 5-89 |
| IEC 60601-2-54:2009+AMD1:2015 | 12-296 |
| IEC 60601-2-63:2012 | 12-251 |
| IEC 61223-3-4:2000 | 12-224 |
| IEC 62304:2006+AMD1:2015 | 13-79 |
| IEC 62366:2007+AMD1:2014 | 5-87 |
| ISO 10993-1:2009/Cor1:2010 | 2-220 |
| ISO 14971:2007 | 5-40 |
{12}------------------------------------------------
In addition to conformance with the above standards, non-clinical testing was conducted on the new device including imaging performance for all three modes of operation (panoramic, cephalometric, and CBCT).
807.92(b)(2): Clinical Testing
There were no clinical tests performed for Veraview X800.
807.92(b)(3): Conclusions from Testing
Based on the comparison of the Veraview X800 to the primary and reference predicates identified above and based on the non-clinical testing described above, it is concluded that the Veraview X800 is substantially equivalent to the primary predicate device.
The Veraview X800 device has the same intended use as the predicate device, and also offers the same imaging modalities as the predicate device (panoramic, cephalometric, and CBCT). Non-clinical testing demonstrates that the device performs in a substantially equivalent manner to the predicate device with regard to imaging and dose performance. Finally, the safety and overall performance of the device are demonstrated via conformance to the above stated applicable standards.
§ 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.