PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.

Device Description

The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D.

The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.

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 and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: PREXION 3D
K Number: K120948

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Premarket Testing	(Implied: demonstrate substantial equivalence to predicate devices and conform to recognized standards)	(Conclusion: PREXION 3D is substantially equivalent to predicate devices FINECUBE (K063622) and CS 9300 (K103659) and does not raise new questions of safety or effectiveness. Meets requirements of recognized consensus/voluntary standards.)
Laser Safety	Compliance with IEC 60825-1	Identical laser system to PANOURA 18S (K111231), which has a test report showing compliance with IEC 60825-1.
Modulation-Transfer Function (Spatial Resolution)	All scan modes must meet acceptance criteria (specific numerical criteria not provided).	The spatial resolution of all scan modes met the acceptance criteria (measured in accordance with IEC 61223-3-5).
Artifact Analysis	No significant difference in pattern and strength of metal artifacts compared to predicate.	No difference in pattern and strength of the metal artifact between the PREXION 3D and the FineCube (K063622) for all scan modes.
Software Verification/Validation	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Software has been validated accordingly.
EMC	Compliance with IEC 60601-1-2	Confirmed (details of specific tests not provided).
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-1	Confirmed (details of specific tests not provided).
X-ray Radiation Safety	Compliance with IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32	Confirmed (details of specific tests not provided).
Risk Analysis	Deemed satisfactory in accordance with ISO14971:2007.	Risk management was deemed satisfactory.

2. Sample Size Used for the Test Set and the Data Provenance

The provided summary does not specify a sample size for a test set in the context of clinical or image-based studies with human subjects. The testing described focuses on technical performance metrics (MTF, artifact analysis) and safety standards, likely using phantoms or laboratory setups rather than patient data for "test sets" in the diagnostic performance sense.

Data Provenance: Not applicable in the context of the described technical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the technical tests (like MTF and artifact analysis) is established by measurement against defined physical standards or comparison to a predicate device's known performance, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the tests were technical and did not involve human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on technical substantial equivalence, not comparative diagnostic effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

No, a standalone algorithm performance study was not explicitly described. The device, an X-ray system, produces images for human healthcare professionals to interpret; it is not presented as an AI-driven diagnostic algorithm. The software validation mentioned pertains to the software's functional correctness for image processing and system control.

7. The Type of Ground Truth Used

For Laser Safety: Compliance with IEC 60825-1 (international standard).
For Modulation-Transfer Function (Spatial Resolution): Measurements in accordance with IEC 61223-3-5 (international standard).
For Artifact Analysis: Comparison to the predicate device (FineCube K063622). The "ground truth" here is the established and accepted performance of the predicate device.
For Software Verification/Validation: Compliance with FDA guidance for software in medical devices.
For EMC, Electrical Safety, X-ray Radiation Safety: Compliance with relevant IEC 60601 series standards.
For Risk Analysis: Compliance with ISO 14971:2007.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set of data. The software validation is for the image acquisition and processing functions, which are deterministic, not for a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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DEC 2 1 2012

510(k) Summary

a. Owner/Company name, address THE YOSHIDA DENTAL MFG CO., LTD. 1-3-6, Kotobashi, Sumida-ku Tokyo 130-8516, Japan
Michizo Yamanaka President

· Contact person Hidenori Watanabe Regulatory Affairs Phone: 011-81-3-3631-2165 Fax: 011-81- 3-3633-9420 Email: hi-watanabe@yoshida-net.co.jp

b. Contact/Application Correspondent

Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

011-81-3-3818-8577 Phone: 011-81-3-3818-8573 Fax: Email: kanaif(@mici.co.jp

c. Date prepared March 28, 2012

d. Name of device

PREXION 3D Trade Name: Computed tomography x-ray system Common Name: Classification Name: X-ray, tomography, computed, dental Classification Regulation: 21 CFR 892.1750

YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012

ATTACHMENT 1 A 1-12 OF A 1-17

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e. Predicate devices

The PREXION 3D is substantially equivalent to the following legally marketed device: .

510(k) Number	Trade name	Product code
K063622	FINECUBE	OAS
K103659	CS 9300	OAS

The predicate devices are hereinafter called "the FINECUBE (K063622)" or "CS 9300 (K103659)" in this application.

f. Description of the device

g. Indications for Use

The PREXION 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.

h. Statement of substantial equivalence

The PREXION 3D was developed from the FINECUBE (K063622) by adding panoramic scan function. Accordingly, the characteristics of the PREXION 3D are identical or similar to those of the FINECUBE (K063622) regarding X-ray Generation Device characteristics including tube voltage, tube current, and Focal Spot Size, X-ray image capturing device including type of detector, Pixel size, pixel number. (See Table 6-1 Comparison Table).

The only difference of the PREXION 3D from the FINECUBE (K063622) is addition of panoramic scanning function. The panoramic scanning function of the PREXION 3D is similar to CS 9300 (K103659). Both the PREXION 3D and CS 9300 (K103659) have the panoramic scanning function in addition to CT scan function. The PREXION 3D has the similar characteristics regarding intended use, X-ray Generation Device characteristics

YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012

ATTACHMENT 1 A1-13 OF A1-17

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including tube voltage, tube current, and Focal Spot Size, X-ray image capturing device including type of detector, pixel number as CS 9300 (K103659).

By considering above device characteristics, the intended use of the PREXION 3D is identical to part of intended use of the CS 9300 (K103659), and similar to the intended use of the FINECUBE (K063622).

In order to ensure same performance characteristics as predicate devices, software verification/validation, performance testing, and risk analysis were performed. Such test results and risk analysis indicate that the PREXION 3D meets the requirements of the recognized consensus or voluntary standard. Based on the information presented above we conclude that the PREXION 3D is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness.

Comparison table i.

Table 6-1 compares the characteristics between the PREXION 3D and the predicates.

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ON 3D (K120948)
ONSE TO FDA LETTER DATED MAY

x 149 mm max (Panoram x 1536 pixels (Panorar PD (TFT ર0 - 90k પ 2 - 15m/ 0.7mm l 4 bits .6mm x 123.2m 608 x 610 0.2mm 200μm l 2bits 90k V 4mA FPD Xion sional pisal managalad to provinsi
Adimensional manakal manakaran para na mana mana mana marka marin
sa of the villaga marka mana mana mana mana mana mana mana mana man 123.2mm x 121.6mm (CT)
mm x 131.6mm (Panoram 616 x 608 (CT)
216 x 72 (Panorami 200μm (CT)
0μm (Panorami 0.2mm 90k V 4bits 4mA FPD Tube Current
Tocal Spot Size Number of B ube Voltag ixel numbe Size of Area
receiving receiving
X-ray le 6-1. Comparison Ts ixel size Detector ications for l X ray Generatic
Device K ray image
capturing devi

SHIDA DENTAL MFG CO.,
VEMBER 9, 2012

ATTACHMENT
A I-15 OF A I-1

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XION 3D (K120948)
K... SPONSE TO FDA LETTER DATED MAY 16, 2012

	PREXION 3D	FINECUBE (K063622)	CS 9300 (K103659)
Scanner	SID/SOD
	700mm/468mm(Hi-Def/Ultra Hi-Def/Rapid Scan)700mm/322mm(Hi-Res)	700mm/322mm(Magnificationimaging)700mm/468mm(Wide areaimaging)	615mm (SID)
	Dimension(W×D×H)	1170mm×1530mm×1930mm	1158mm×1595mm×2378mm
	Weight	390kg	390kg	160kg
Scan mode		CT Scan and Panoramic Scan	CT Scan	CT Scan and Panoramic Scan
Panoramic scanPerformance	Scan time	16.2 sec		4 - 16 sec
	Scan time	8.6 sec(Rapid Scan)16.8 sec(Hi-Def/Hi-Res)33.5 sec(Ultra Hi-Def/Ultra Hi-Res)	19sec. (Standard mode)37sec. (High density mode)	12 - 20 sec28 sec
CT scanPerformance		φ81mm/H74mm(Hi-Def/Ultra Hi-Def/Rapid Scan)φ56mm/H51mm(Hi-Res/Ultra Hi-Res)	Wide area imagingφ82.0mm H75.1mmMagnification imagingφ56.5mm, H51.7mm	φ170mm/H135mm(0.090mm - 0.500mm)φ170mm/H110mm(0.090mm-0.500mm)φ170mm/H60mm(0.090mm - 0.500mm)φ100mm/H100mm(0.090mm - 0.500mm)φ80mm/H80mm(0.090mm - 0.500mm)φ100mm/H50mm(0.090mm - 0.500mm)φ50mm/H50mm(0.090mm-0.500mm)
	FOV(voxel size)

ATTACHMENT ]
A1-16 OF A1-17

YOSHIDA DENTAL MFG CO., LTD
NOVEMBER 9, 2012

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j. Risk Analysis

The PREXION3D was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory.

k. Bench Testing

THE YOSHIDA DENTAL MFG CO., LTD has performed bench tests to ensure safety and effectiveness as follows;

1. Laser safety

The laser system of the PREXION3D is identical to that of the PANOURA 18S (K111231). Therefore, the test report for IEC 60825-1 for the PANOURA 18S (K111231) is used as the test report for the PREXION3D.

2. Modulation-Transfer Function

In order to evaluate the spatial resolution of the PreXion3D, we measured the MTF in accordance with IEC 61223-3-5. The spatial resolution of all scan modes met the acceptance criteria.

3. Artifact Analysis

In order to evaluate the artifact of the image of the PREXION 3D, the images of all scan mode of the PREXION 3D were compared to those of the FineCube (K063622). There was no difference of pattern and strength of the metal artifact between the PREXION 3D and the FineCube(K063622).

The software of the PREXION3D has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.

I. Conclusion

The PREXION 3D has similar intended use and technical characteristics as the predicate devices including the FINECUBE (K063622) and CS 9300 (K103659). A number of test results and risk analysis indicate that the PREXION 3D meets the requirements of the recognized consensus or voluntary standard. Based on those information, we conclude that the PREXION 3D is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness.

YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012

· ATTACHMENT 1 A1-17 OF A1-17

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 21, 2012

The Yoshida Dental MFG Co., LTD. % Dr. Fumiaki Kanai President and CEO MIC international 4-1-17 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN

Re: K120948

Trade/Device Name:PREXION 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: OAS Dated: November, 09, 2012 Received: November 13, 2012

Dear Dr. Kanai:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Dr. Kanai

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120948

Device Name: PreXion 3d

Indications For Use:

PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -S 2012.12.21 10:48:57 -05'00'

Page 1 of

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.