(57 days)
No
The summary describes standard image reconstruction and processing techniques for X-ray data, but there is no mention of AI, ML, or related concepts like training/test sets, performance metrics associated with AI/ML, or specific AI/ML algorithms.
No
The device is used to produce diagnostic images, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to produce digital x-ray images "as diagnostic support." This clearly indicates its role in the diagnostic process.
No
The device description explicitly states that the device consists of a scanner (hardware for generating and detecting X-rays) and a console (hardware for operating the scanner and managing data), in addition to the software for image analysis and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PreXion3D Explorer PRO is an X-ray imaging system. It generates X-rays that pass through the patient's body and are detected to create images. It does not perform tests on samples taken from the body.
- Intended Use: The intended use is to produce digital X-ray images for diagnostic support. This is a form of in vivo (within the living body) imaging, not in vitro (in glass, or outside the body) testing.
- Device Description: The description details the process of acquiring X-ray data by rotating around the patient's head and detecting the X-rays that pass through. This is consistent with an imaging device, not an IVD.
Therefore, the PreXion3D Explorer PRO falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
OAS
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 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.
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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region, hand and wrist
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- . 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"
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K193329, PreXion3D Explorer EX, K190320, PreXion3D Explorer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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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 Classification
Name | X-Ray, Tomography, Computed, Dental | Same | Same | Same | |
| | PreXion3D Explorer
PRO 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 | PreXion3D Explorer
EX 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. | PreXion3D Explorer 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 | | |
| Indications for use: | obtain carpus images
for growth and
maturity assessment.
This device is not
intended for use on
patients less than
approximately 21 kg
(46 lb) in weight and
113 cm (44.5 in) in
height; these height
and weight
measurements
approximately
correspond to that of
an average 5 year-
old. Use of
equipment and
exposure settings
designed for adults of
average size can
result in excessive
radiation exposure
for a smaller patient.
Studies have shown
that pediatric
patients may be
more radiosensitive
than
adults (i.e., the
cancer risk per unit
dose of ionizing | This device is not
intended for use on
patients less than
approximately 21
kg (46 lb) in weight
and 113 cm (44.5
in) in height; these
height and weight
measurements
approximately
correspond to that
of an average 5
year-old. Use of
equipment and
exposure settings
designed for adults
of average size can
result in excessive
radiation exposure
for a smaller
patient. Studies
have shown that
pediatric patients
may be more
radiosensitive than
adults (i.e., the
cancer risk per unit
dose of ionizing | patients.
Cephalometric
imaging also includes
the hand and wrist to
obtain carpus images
for growth and
maturity assessment. | Similar | |
| radiation is higher),
and so unnecessary
radiation exposure is
of particular concern
for pediatric patients. | | | radiation is higher),
and so unnecessary
radiation exposure
is of particular
concern for
pediatric patients. | | |
| Patient/User Characteristics | | | | | |
| Target Population | | Children aged 6
(except infants) to
elderly | Same | Same | Same |
| Anatomical Site | | The dental, oral,
maxillofacial region
ENT (Ear, Nose and
Throat) and neck
region | Same | Same | Same |
| Users | | Health care
professionals | Same | Same | Same |
| Technological Characteristics and Performance | | | | | |
| Patient Contact
Material | | CHIN REST:
polycarbonate
Forehead Holder:
silicone rubber
HANDLE GRIP:
silicone rubber | Same | CHIN REST:
polycarbonate
HEADREST: carbon
BELT: polyvinyl
chloride | Biocompatibili
ty test results
support that
the material
is safe for the
intended use. |
| Sterility | | Non-sterile | Same | Same | Same |
| | Tube
Voltage | 90-110KV | 90-110KV | 90-110KV | Same |
| X-ray
Generati | Pulse
Exposure
function | Yes | Yes | Yes | Same |
| on
Device | Tube
Current | 1-5.3mA | 1-5mA | 1-5mA | Same |
| | Focal
Spot Size | 0.3mm x 0.3mm | Same | Same | Same |
| | Detector | FPD (TFT) | Same | Same | Same |
| X-ray
Image
Capturin
g Device | Pixel
Size | 248 $μ$ m x248 $μ$ m
(With binning)
(CT, CT-Panoramic, | 248 $μ$ m x248 $μ$ m
(With binning)
(CT, CT-Panoramic, | Same | Same as
secondary
predicate
device |
| | | 124 μm x124μm
(Without binning)
(CT, CT-Panoramic,
Panoramic, Ceph) | 124 μm x124µm
(Without binning)
(CT, CT-Panoramic,
Panoramic)
*No Ceph Function | | |
| | | 1024x1280(With
binning)
(CT, CT-Panoramic) | 1024x1280(With
binning)
(CT, CT-Panoramic) | 1024x1280(With
binning)
(CT, CT-Panoramic) | Regarding
СТ, СТ-
Panoramic,
all same |
| | Pixel
Number | 2560x2048(Without
binning)
(CT, CT-Panoramic,
Ceph) | 2560x2048(Without
binning)
(CT, CT-Panoramic)
*No Ceph Function | 2560x2048(Without
binning)
(CT, CT-Panoramic,
Ceph) | Regarding
Ceph, same
as secondary
predicate
device |
| | | 1900 x 120
(Panoramic) | 1900 x 120
(Panoramic)
*No Ceph Function | *No Panoramic
Function | Regarding
Panoramic
same as
primary
predicate |
| | | 2112x1754
(Cephalometric) | | | device |
| | | 253.95mm x
317.44mm
(CT, CT-Panoramic) | 253.95mm x
317.44mm
(CT, CT-Panoramic) | 253.95mm x
317.44mm
(CT, CT-Panoramic) | Regarding
СТ, СТ-
Panoramic,
all same. |
| | Size of
Area
Receivin
g X-ray | 230mm x 15mm
(Panoramic) | 230mm x 15mm
(Panoramic) | *No Panoramic
Function | Regarding
Panoramic
same as
primary
predicate
device |
| | | 253.95mm x
317.44mm (Ceph) | *No Ceph Function | 253.95mm x
317.44mm (Ceph) | Regarding
Ceph, same
as secondary
predicate
device |
| | | | | | |
| | Number
of 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 | Dimensi
on
(WxDxH) | 1164 mm x 1690 mm
x 2330 mm (CT, CT-
Panoramic,
Panoramic, Ceph) | 880 mm x 1267 mm
x 2268 mm (CT,
CT-Panoramic,
Panoramic) | 880 mm x 1267 mm
x2268 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,
Cephalometric
radiography | CT scan, Panoramic
scan,
*No Ceph Function | CT scan, CT-
Panoramic,
Cephalometric
radiography | Same as
secondary
predicate
device |
| Panoramic Scan
Performance (Scan
Time) | | 8-16sec | 8-16sec | 18sec | Similar |
| Cephalometric
Radiography (Scan
Time) | | 0.16sec | N/A | 0.16sec | Same as
secondary
predicate
device |
| CT Scan
Performance | Scan
Time | 10-20sec | 10-20sec | 10-20sec | Same |
| | FOV
(Voxel
Size) | Diameter 150mm x
H156mm (0.100 -
0.200mm) | Same | Diameter 150mm x
H156mm (0.100 -
0.200mm) | Same as
primary
predicate
device |
| | Diameter 150mm x
H100mm (0.100 -
0.200mm) | Diameter 150mm x
H78mm (0.100 -
0.200mm) | | | |
| | Diameter 100mm x
H100mm (0.100 -
0.200mm) | | | | |
| | Diameter 50mm x
H50mm
(0.100 - 0.200mm) | Diameter 50mm x
H50mm
(0.100 - 0.200mm) | | | |
| | | Applied Standard | | | |
| Electrical Safety
Standard | | ANSI/AAMI ES60601-
1 | Same | Same | Same |
| Electromagnetic
Compatibility
Standard | | IEC 60601-1-2 | Same | Same | Same |
| Radiation Safety
Standard | | IEC 60601-1-3 | Same | Same | Same |
| Electrical Equipment
Usability Safety
Standard | | IEC 60601-1-6 | Same | Same | Same |
| Usability
Engineering
Standard | | IEC 62366 | Same | Same | Same |
| Software Lifecycle
Process 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.
| Essential
performance of
dental extra-oral X-
ray equipment
| Standard | IEC 60601-2-63 | |
|---|---|---|
| Acceptance tests of | ||
| Imaging | ||
| performance of | ||
| dental X-ray | ||
| equipment Standard | IEC 61223-3-4 | |
| Acceptance tests of | ||
| Imaging | ||
| performance of | ||
| computed | ||
| tomography X-ray | ||
| equipment Standard | IEC 61223-3-5 | |
| Laser Safety | ||
| Standard | IEC 60825-1 | |
| Risk Management | ||
| Standard | ISO 14971 | |
| DICOM Standard | NEMA PS 3.1 - 3.20 | |
| Biocompatibility | ||
| Standard | ||
| Compliance | ISO 10993-1 | |
| Biocompatibility | ||
| Standard | ||
| Compliance | ISO 10993-5 | |
| Biocompatibility | ||
| Standard | ||
| Compliance | 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.