Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and reconstruction techniques for medical imaging, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is intended to produce diagnostic images, not to provide therapy or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "diagnostic support." Additionally, the "Device Description" mentions that the detected x-ray absorption data is processed to "reconstruct the diagnostic images."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the PreXion3D Excelsior 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.

IVD (In Vitro Diagnostic)

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 Excelsior is an imaging device that uses X-rays to create images of internal anatomical structures (maxillofacial, ENT, hand/wrist). It does not analyze biological samples taken from the patient.
Intended Use: The intended use is to produce images for diagnostic support, not to perform tests on biological specimens.

The device is a medical imaging system, specifically a cone-beam CT and panoramic/cephalometric X-ray system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

Product codes (comma separated list FDA assigned to the subject device)

OAS

Device Description

PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

maxillofacial, and ENT (Ear, Nose and Throat) region, hand and wrist (for carpus images)

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)

Verification/validation testing were performed to support the software modifications. Electrical safety, EMC/EMI testing were not performed because there are not any hardware modifications. The assessment of 3D MTF for the subject device was performed to the stitching area of the volume data of Complete mode and confirmed that the results met the predicate device criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161881

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

PreXion Corporation % Mr. Katsumi Hayashi Director 1-14-1 Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN

January 19, 2018

Re: K173878

Trade/Device Name: PreXion3D Excelsior Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 19, 2017 Received: December 21, 2017

Dear Mr. Hayashi:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Michael D. O'Hara For

Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173878

Device Name

PreXion3D Excelsior

Indications for Use (Describe).

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

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."

FORM FDA 3881 (7/17)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

510(k) Number: K173878

Applicant Information

Date Prepared:	Jan. 15th, 2018
Company Name and
Address:	PreXion Corporation

1-14-1 Kandasuda-cho, Chiyoda-ku
Tokyo, 101-0041
Japan |
| Contact Person: | Mr. Katsumi Hayashi
Director, Quality Assurance and Regulatory Division
Phone: +81-3-5297-7551
FAX: +81-3-5297-7552
Email: hayashi@prexion.co.jp |

Device Information

Type of 510(k) Submission	Special
Device Type:	Dental Cone-beam Computed Tomography
Regulation Description:	Computed Tomography X-Ray System
Review Panel:	Radiology
Regulation Number:	21 CFR 892.1750
Product Code:	OAS
Device Class:	II
Device Name:	PreXion3D Excelsior

Predicate Device Information

The legally marketed devices to which substantial equivalence is being claimed are:

510(k) Number:	K161881
Device Type:	Dental Cone-beam Computed Tomography
Regulation Description:	Computed Tomography X-Ray System
Review Panel:	Radiology
Regulation Number:	21 CFR 892.1750
Product Code:	OAS
Device Class:	II
Device Name:	PreXion3D Excelsior

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Device Description

PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

Intended Use/Indications for Use

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.

Comparison to the Predicate Device

We added a Complete mode of CT Scan to the Predicate Device(K161881). That function simulatively creates a widen FOV. FOV height is extended from 81mm to 130mm. FOV width is same as one of Wide mode in CT Scan.

Device	Predicate Device(K161881)	Modified Device
	PreXion3D Excelsior	PreXion3D Excelsior
Intended
Use/Indications for
Use	PreXion3D Excelsior is intended to
produce two dimensional digital
panoramic and cephalometric
images, and three dimensional
digital x-ray images of the
maxillofacial, and ENT (Ear, Nose
and Throat) region at the direction
of healthcare professionals as
diagnostic support for adult and
pediatric patients.
Cephalometric imaging also
includes the hand and wrist to
obtain carpus images for growth
and maturity assessment.	Same
X-ray
Gene	Tube
Voltage
60-110KV	Same
Device		Predicate Device(K161881)
PreXion3D Excelsior	Modified Device
PreXion3D Excelsior
ration
Devic
e	Pulse
Exposure
function	Yes	Same
	Tube
Current	1-6mA	Same
	Focal Spot
Size	0.3mm	Same
	Detector	FPD (TFT)	Same
	Pixel Size	125 μm x125μm,125µm
x250µm(CT)

125 μm x 125µm(Panoramic)

128x1280 (Panoramic)

160mm x 12.5mm (Panoramic)

The subject device compares to the legally marketed devices as follows:

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Summary of Performance Testing

Verification/validation testing were performed to support the software modifications. Electrical safety, EMC/EMI testing were not performed because there are not any hardware modifications. The assessment of 3D MTF for the subject device was performed to the stitching area of the volume data of Complete mode and confirmed that the results met the predicate device criteria.

Conclusions

The subject device has the same intended use/Indications for use as the predicate device. The subject and predicate device also almost same such as specifications of X-ray Generation Device, Xray Image Capturing Device and Scanner, Imaging Mode, Panoramic Scan Performance, Cephalometric Radiography, Spatial Resolution and conformance with performance standards.

The subject and predicate device also have differences in technological characteristics, such as FOV (Voxel Size), Volume Size and Dose Level (CTDIw) in CT Scan Performance.

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and performance testing that the subject device is substantially equivalent to the legally marketed device identified in this submission.