VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K120263 · Genoray Co., Ltd. · MUH · Jul 10, 2012 · Dental

Device Facts

• Record ID: K120263
• Device Name: VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
• Applicant: Genoray Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

VOLUX 21C is a dental diagnostic imaging system; performs panoramic, cephalometric, and computed tomography (CT) radiography. System utilizes high-frequency stationary X-ray tube and digital detectors (CMOS for CT/panorama; CCD for cephalometry). Device acquires 360° rotational X-ray sequences of oral and craniofacial anatomy; computer reconstructs data into diagnostic images. Operated by physicians, dentists, or X-ray technicians in clinical settings. Output provides clinicians with anatomical visualizations for treatment planning. System features standing patient positioning; reconstruction time approximately 2.5 minutes. Device benefits patients by enabling precise diagnostic assessment of craniofacial structures.

Clinical Evidence

Bench testing only. Performance evaluated against IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-44, and IEC 60601-1-2 (EMC). Image quality and performance verified per IEC 61223-3-4 and IEC 61223-3-5 and FDA guidance for Solid State X-ray Imaging Devices. All results satisfactory.

Technological Characteristics

High-frequency stationary X-ray tube (60-110 kV); CMOS flat panel detector (CT/Panorama) and CCD detector (Cephalo). Reconstruction: Cone beam (CT), Fan beam (Panorama). Total filtration 2.5mmAl. Connectivity: DICOM 3.0 compatible. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-44, IEC 61223-3-4, IEC 61223-3-5.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic, cephalometric, or cross-sectional diagnostic imaging of oral and craniofacial anatomy for treatment planning.

Regulatory Classification

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.

Predicate Devices

• PaX-Reve3D Plus (K102124)

Submission Summary (Full Text)

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**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 [phone] Telephone No.: Fax: [phone]
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: [e-mail] 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)

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## રું ર Description of the Device

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.

| Product<br>Items | VOLUX 21C |
|-----------------------------|------------------------------------------------------------------------------------------------|
| X-ray Source | High Frequency, Stationary tube,<br>60~110 kV 5~7mA (CT, Panorama)<br>60~110 kV 20mA (Cephalo) |
| Focal Spot | 0.5mm, 1.5mm |
| Image Detector | CMOS flat panel(CT, Panorama)<br>CCD(Cephalo) |
| FOV | CT : 145mm x 85mm<br>Panorama : 144 x 330mm<br>Cephalo : 240mm x 300mm |
| Image Acquisition (CT) | 360° |
| Scan time / exposure time | CT : 15.8 sec<br>Panorama : 17.1 sec<br>Cephalo : 0.5~2 sec |
| Power Voltage / Input power | 120V~, 60Hz, 4.8 KVA |
| Total filtration | 2.5mmAl<br>(inherent :0.5mmAl, Added : 2.0mmAl) |
| Patient position | Standing |
| Reconstruction type | Cone beam (CT)<br>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.

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### 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 |
| Indications<br>for use | VOLUX 21C is a Computed tomography<br>X-ray system intended to produce<br>panoramic, cephalometric or cross-<br>sectional images of the oral and<br>cranioifacial anatomy on a real time basis<br>by computer reconstruction of x-ray<br>image data from the same axial plane<br>taken at different angles. It provides<br>diagnostic images of the anatomic<br>structures by acquiring 360°rotational<br>image sequences of oral and craniofacial<br>area for a precise treatment planning in<br>adult and pediatric care. The device is<br>operated and used by physicians, dentists<br>and x-ray technicians. | PaX-Reve3D Plus is a Computed<br>tomography X-ray system intended to<br>produce panoramic, cephalometric or<br>cross-sectional images of the oral and<br>cranioifacial anatomy on a real time basis<br>by computer reconstruction of x-ray<br>image data from the same axial plane<br>taken at different angles. It provides<br>diagnostic details of the anatomic<br>structures by acquiring 360° rotational<br>image sequences of oral and cranioifacial<br>area for a precise treatment planning in<br>adult and pediatric care The device is<br>operated and used by physicians, dentists,<br>and x-ray technicians. |
| Performance<br>Specification | Panoramic, Cephalometric and Computed<br>tomography | Panoramic, Cephalometric and Computed<br>tomography |
| Input Voltage | 120V~ | 110V~ |
| Tube Voltage | 60~110 kV | 50-100kV |
| Tube Current | 5~7mA (CT, Panorama)<br>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 Imaging<br>Volume | CT : 145mm x 85mm<br>Panorama : 144mm x 330mm<br>Cephalo : 240mm x 300mm | 150x150mm, 120x80mm,<br>80x60mm, 50x50 mm |
| Slice Width | 0.14mm min | 0.1mm min |
| Total Filtration | 2.5mmAl | 2.8mmAl |
| Pixel Size | CT : 150 µm<br>Panorama : 150 µm<br>Cephalometric : 160 µm | CT : 200 µm.<br>Panorama : 100 µm<br>Cephalometric : 127µm |
| Image Receptor | CT with Flat Panel Detector<br>Cephalo with CCD Detector | CT with Flat Panel Detector |
| Chin Rest | Equipped Chinrest | Equipped Headrest |
| Performance<br>Specification | Computed tomography | Computed tomography |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical Sites | Maxillofacial | Maxillofacial |

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K120263
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Indications for use, safety characteristics for panoramic and non-clinical performance for panmetric of Volux 21C and PaX-Reve3D Plus are similar.

- 8. 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.

- 9. 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.

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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

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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 [phone]. 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 [phone] or [phone] 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

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## 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:

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.

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