VOLUX 21C is a Computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians.

Device Description

VOLUX 21C is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometry and computed tomography. VOLUX 21C designed for dental radiography of the oral and craniofacial anatomy. VOLUX 21C is equipped with extra-oral x-ray detector based on CMOS digital X-ray detector, CT & panoramic radiography with an extra-oral x-ray tube. CMOS digital X-ray detector is used to capture scanned image in 3D for obtaining diagnostic information for craniofacial surgery or other treatments. And VOLUX 21C can also be operated as the cephalometric dental x-ray system based on CCD X-ray detector.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, VOLUX 21C, by the FDA. It does not contain detailed information about specific acceptance criteria being met through a dedicated study with quantified performance metrics, sample sizes, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards.

However, I can extract the information that is present and indicate what is not explicitly detailed.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance reports in the way one would expect for a study. It instead focuses on substantial equivalence to the predicate device, PaX-Reve3D Plus, by comparing technical specifications and intended use. The "Performance Specification" is listed as "Panoramic, Cephalometric and Computed tomography" for both the new device and the predicate, implying functional equivalence rather than quantitative performance thresholds.

Feature	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (VOLUX 21C)
Indications for Use	"Produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians." (Identical to predicate)	"Produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians."
Imaging Modalities	Panoramic, Cephalometric and Computed tomography (Identical to predicate)	Panoramic, Cephalometric and Computed tomography
Input Voltage	~~110V (Predicate: 110V~~)	120V~
Tube Voltage	50-100kV (Predicate)	60~110 kV
Tube Current	2-10mA (Predicate)	5~7mA (CT, Panorama), 20mA (Cephalo)
Focal Spot Size	0.5mm (Predicate)	0.5mm, 1.5mm
Exposure Time	0.5-24s (Predicate)	0.5-17s (Various)
CT FOV	150x150mm, 120x80mm, 80x60mm, 50x50 mm (Predicate)	145mm x 85mm
Slice Width	0.1mm min (Predicate)	0.14mm min
Total Filtration	2.8mmAl (Predicate)	2.5mmAl
Pixel Size (CT)	200 µm (Predicate)	150 µm
Image Receptor	CT with Flat Panel Detector (Predicate)	CT with Flat Panel Detector, Cephalo with CCD Detector
Safety and Performance	Satisfactory results from tests against IEC 60601 series, IEC 61223 series, and FDA Guidance for Solid State X-ray Imaging Devices. (Implied)	"All test results were satisfactory." and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (General statement of compliance)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices," but it does not provide details on the sample size used for the clinical evaluation, data provenance (country of origin), or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The text refers to "clinical evaluation" but does not detail how ground truth was established or the qualifications of any experts involved in that process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a conventional medical imaging device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable in this context. The evaluation is focused on the device's inherent imaging capabilities and safety compared to a predicate X-ray system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an AI algorithm's performance. As mentioned above, this device is a traditional X-ray system, not an AI-driven one. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not explicitly provided in the document. The statement "clinical evaluation" is too general to infer the type of ground truth used.

8. The sample size for the training set

This refers to AI model training. Since the device is a conventional X-ray system and not an AI algorithm, there is no mention of a training set.

9. How the ground truth for the training set was established

As there is no training set mentioned for an AI model, this information is not applicable.

Summary

{0}------------------------------------------------

Exhibit 5 510(k) Summary

Date of Summary Preparation: January 20, 2012

Submitter and US Official Correspondent 1 . GENORA Y Co., Ltd. Submitter: Address: #512, Byucksan Technopia 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city Gyeonggi-do. 462-716, Korea +82-31-740-4100 Telephone No.: Fax: +82-31-737-8025
K120263

Official Correspondent (U.S): Jae Kim - Business Manager GENORAY America Inc. Correspondent : Address: 1073 N. Batavia St. Orange, CA 92867, USA Telephone No .: 714-289-8020 714-453-9661 Fax: jae@genorav.com Email:

Establishment Registration Number 2. 3005843418

3. Device Information

Proprietary/Trade Name: Computed tomography X-ray system / VOLUX 21C Common/Usual Name: Computed tomography X-ray system Classification Name: X-ray, Tomography, Computed Product Code: OAS Device Class: Class II per regulation 21 CFR 892.1750

Equivalent Legally Marketed Device 4. < PaX-Reve3D Plus > Manufacturer: Device Name: 510(k) Number:
Vatech Co., Ltd. PaX-Reve3D Plus K 102124 (Decision Date: Oct. 22, 2010)

{1}------------------------------------------------

K120263
Page 2 of 4

રું ર Description of the Device

ProductItems	VOLUX 21C
X-ray Source	High Frequency, Stationary tube,60~~110 kV 5~~7mA (CT, Panorama)60~110 kV 20mA (Cephalo)
Focal Spot	0.5mm, 1.5mm
Image Detector	CMOS flat panel(CT, Panorama)CCD(Cephalo)
FOV	CT : 145mm x 85mmPanorama : 144 x 330mmCephalo : 240mm x 300mm
Image Acquisition (CT)	360°
Scan time / exposure time	CT : 15.8 secPanorama : 17.1 secCephalo : 0.5~2 sec
Power Voltage / Input power	120V~, 60Hz, 4.8 KVA
Total filtration	2.5mmAl(inherent :0.5mmAl, Added : 2.0mmAl)
Patient position	Standing
Reconstruction type	Cone beam (CT)Fan beam (Panorama)
Reconstruction time	2.5 minutes
Main body weight	300 kg ± 5kg
Main body dimension	1449 x 2111.5 x 2307 mm

Indications for use 6.

VOLUX 21C is a Computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians.

{2}------------------------------------------------

K120263
Page 3 of 4

7. Substantial equivalence chart

Name	VOLUX 21C	PaX-Reve3D Plus
Manufacturer	GENORAY Co., Ltd.	Vatech Co., Ltd.
510(k) No.		K102124
Figure	Image: VOLUX 21C	Image: PaX-Reve3D Plus
Indicationsfor use	VOLUX 21C is a Computed tomographyX-ray system intended to producepanoramic, cephalometric or cross-sectional images of the oral andcranioifacial anatomy on a real time basisby computer reconstruction of x-rayimage data from the same axial planetaken at different angles. It providesdiagnostic images of the anatomicstructures by acquiring 360°rotationalimage sequences of oral and craniofacialarea for a precise treatment planning inadult and pediatric care. The device isoperated and used by physicians, dentistsand x-ray technicians.	PaX-Reve3D Plus is a Computedtomography X-ray system intended toproduce panoramic, cephalometric orcross-sectional images of the oral andcranioifacial anatomy on a real time basisby computer reconstruction of x-rayimage data from the same axial planetaken at different angles. It providesdiagnostic details of the anatomicstructures by acquiring 360° rotationalimage sequences of oral and cranioifacialarea for a precise treatment planning inadult and pediatric care The device isoperated and used by physicians, dentists,and x-ray technicians.
PerformanceSpecification	Panoramic, Cephalometric and Computedtomography	Panoramic, Cephalometric and Computedtomography
Input Voltage	120V~	110V~
Tube Voltage	60~110 kV	50-100kV
Tube Current	5~7mA (CT, Panorama)20mA (Cephalo)	2-10mA
Focal Spot Size	0.5mm, 1.5mm	0.5mm
Exposure Time	0.5-17s (Various)	0.5-24s (Various)
Size of ImagingVolume	CT : 145mm x 85mmPanorama : 144mm x 330mmCephalo : 240mm x 300mm	150x150mm, 120x80mm,80x60mm, 50x50 mm
Slice Width	0.14mm min	0.1mm min
Total Filtration	2.5mmAl	2.8mmAl
Pixel Size	CT : 150 µmPanorama : 150 µmCephalometric : 160 µm	CT : 200 µm.Panorama : 100 µmCephalometric : 127µm
Image Receptor	CT with Flat Panel DetectorCephalo with CCD Detector	CT with Flat Panel Detector
Chin Rest	Equipped Chinrest	Equipped Headrest
PerformanceSpecification	Computed tomography	Computed tomography
Software	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Anatomical Sites	Maxillofacial	Maxillofacial

. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . .

{3}------------------------------------------------

K120263
Page 4 of 4

Indications for use, safety characteristics for panoramic and non-clinical performance for panmetric of Volux 21C and PaX-Reve3D Plus are similar.

1. Safety, EMC and Performance data comparison to Predicate
- Electrical, mechanical, environmental safety and performance testing according to standard IEC . 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 were performed.
- EMC testing was conducted in accordance with standard IEC 60601-1-2. . .
- FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging -Devices" was performed.
- Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. ﮯ

All test results were satisfactory.

The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

1. Conclusion
  In reference to the comparison information provided in substantial equivalence chart, most of function , and electronic feature are similar in both products. We believe that the VOLUX 21C is safe, effective and substantially equivalent in clinical & technical expect with the predicate devices, Pax-Reve3D Plus.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread. The eagle is facing to the left.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

GENORAY Co., Ltd. % Mr. Jae H. Kim Sales & Marketing Manager Genoray America Inc. 1073 N. Batavia Street, Suite A ORANGE CA 92867

JUL 1 0 2012

Re: K120263

Trade/Device Name: Computed tomography X-ray system (Model: VOLUX 21C) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS and MUH Dated: June 26, 2012 Received: June 28, 2012

Dear Mr. Kim:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{5}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 Diagnostic Device Evaluation and Safety 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

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Exhibit 4 Indications for use

510(k) number (if known): 15 120262

Device Name: Computed tomography X-ray system (Model: VOLUX 21C)

Indications for Use:

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Am. L. D. O/h
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120263

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.