(162 days)
Not Found
No
The summary describes a standard CT X-ray system with computer reconstruction, but there is no mention of AI or ML in the device description, intended use, or performance studies. The lack of information on training/test sets and key metrics further supports this conclusion.
No
The device is described as a diagnostic imaging system that produces images for precise treatment planning, not for administering therapy.
Yes
The "Intended Use / Indications for Use" states that the device "provides diagnostic images of the anatomic structures," and the "Device Description" explicitly calls it a "diagnostic imaging system."
No
The device description explicitly states it is a "diagnostic imaging system" equipped with hardware components like an "extra-oral x-ray detector based on CMOS digital X-ray detector," a "CT & panoramic radiography with an extra-oral x-ray tube," and a "CCD X-ray detector." This indicates it is a hardware device with integrated software for image reconstruction and processing, not a software-only medical device.
Based on the provided information, the VOLUX 21C is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VOLUX 21C Function: The VOLUX 21C is an X-ray imaging system that produces images of the oral and craniofacial anatomy. It works by using X-rays to create images of internal structures, not by analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for producing images for diagnostic purposes, not for performing tests on biological samples.
Therefore, the VOLUX 21C falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OAS, MUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral and craniofacial anatomy, Maxillofacial
Indicated Patient Age Range
adult and pediatric care
Intended User / Care Setting
operated and used by physicians, dentists and x-ray technicians.
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)
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.
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.
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.
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
§ 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.
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. 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
| Items | VOLUX 21C |
|---|---|
| X-ray Source | High Frequency, Stationary tube, |
| 60 | |
| 60~110 kV 20mA (Cephalo) | |
| Focal Spot | 0.5mm, 1.5mm |
| Image Detector | CMOS flat panel(CT, Panorama) |
| CCD(Cephalo) | |
| FOV | CT : 145mm x 85mm |
| Panorama : 144 x 330mm | |
| Cephalo : 240mm x 300mm | |
| Image Acquisition (CT) | 360° |
| Scan time / exposure time | CT : 15.8 sec |
| Panorama : 17.1 sec | |
| Cephalo : 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.
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a
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 | ||
| 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. | PaX-Reve3D Plus 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 details of the anatomic | ||
| structures by acquiring 360° rotational | ||
| image sequences of oral and cranioifacial | ||
| area for a precise treatment planning in | ||
| adult and pediatric care The device is | ||
| operated and used by physicians, dentists, | ||
| and x-ray technicians. | ||
| Performance | ||
| Specification | Panoramic, Cephalometric and Computed | |
| tomography | Panoramic, Cephalometric and Computed | |
| tomography | ||
| 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 Imaging | ||
| Volume | CT : 145mm x 85mm | |
| Panorama : 144mm x 330mm | ||
| Cephalo : 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 µm | |
| Panorama : 150 µm | ||
| Cephalometric : 160 µm | CT : 200 µm. | |
| Panorama : 100 µm | ||
| Cephalometric : 127µm | ||
| Image Receptor | CT with Flat Panel Detector | |
| Cephalo with CCD Detector | CT with Flat Panel Detector | |
| Chin Rest | Equipped Chinrest | Equipped Headrest |
| Performance | ||
| 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.
-
- 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.
-
- 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.
- Conclusion
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:
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