(279 days)
No
The summary describes standard 3D reconstruction and viewing software for cone beam CT data, with no mention of AI or ML algorithms for image analysis, diagnosis, or planning support beyond basic visualization and navigation.
No
The device is an x-ray imaging system used for diagnostic support and planning, not for delivering therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "for use in planning and diagnostic support."
No
The device description explicitly states that the VOLUX comprises the "VOLUX-device," which generates the x-ray beam and rotates around the patient's head. This indicates a hardware component is integral to the device's function, in addition to the software modules.
Based on the provided information, the VOLUX device 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 Function: The VOLUX is an x-ray imaging device that captures images of the head area. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for "planning and diagnostic support" based on imaging data, not on the analysis of in vitro samples.
Therefore, the VOLUX falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support. VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.
Product codes
MUH
Device Description
The VOLUX comprises of the VOLUX-device, the reconstruction server and the 2D and 3D viewing client TRIANA. The VOLUX device generates a conical x-ray beam that rotates round the patient's head within a ccrtain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The VOLUX features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
head area, which includes dental and maxillofacial areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Digital Extraoral Source X-Ray System / Model: VOLUX
APR 2 6 2010
| 1. | Submitter and US Official Correspondent |
|---|---|
| Submitter: | GENORAY Co., Ltd. |
| Address: | #512, Byucksan Technopia |
| 434-6, Sangdaewon 1-dong, | |
| Jungwon-gu, Seongnam-city | |
| Gyeonggi-do, 462-716, Korea | |
| Telephone No.: | +82-31-737-8020 |
| Fax: | +82-31-737-8025 |
Official Correspondent (U.S): Jae Kim - Business Manager
| Correspondent : | GENORAY America Inc. |
|---|---|
| Address: | 1073 N. Batavia St. |
| Orange, CA 92867, USA | |
| Telephone No .: | 714-289-8020 |
| Fax: | 714-453-9661 |
| Email: | jac@genorav.com |
2. Establishment Registration Number 3005843418
3. Device Information
| Proprietary/Trade Name: | Digital Extraoral Source X-Ray System / Model: VOLUX |
|---|---|
| Common/Usual Name: | Digital Extraoral Source X-Ray System |
| Classification Name: | System , X-ray, Extraoral Source, Digital |
| Product Code: | MUH |
| Device Class: | Class II per regulation 21 CFR 872.1800 |
4. Equivalent Legally Marketed Device
| Manufacturer: | Hitachi Medical Systems America, Inc. |
| Device Name: | CB MercuRay |
| 510(k) Number: | K033248 (Decision Date - October 20, 2003) |
| Classification: | System, X-Ray, Extraoral Source, Digital : MUH, |
| Class II per regulation 21 CFR 872.1800 |
.
1
| Manufacturer: | Sirona Dental Systems GmbH, |
| Device Name: | Galileos |
| 510(k) Number: | K060892 (Decision Date - April 14, 2006) |
| Classification: | System, X-Ray, Extraoral Source, Digital : MUH, |
| Class II per regulation 21 CFR 872.1800 |
5. Description of the Device
The VOLUX comprises of the VOLUX-device, the reconstruction server and the 2D and 3D viewing client TRIANA. The VOLUX device generates a conical x-ray beam that rotates round the patient's head within a ccrtain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The VOLUX features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.
| Product | VOLUX |
|---|---|
| Items | |
| kV range | 60~85kV |
| mA range | 5~7mA |
| mAs range | 30~42mAs |
| X-ray Source Mode | Pulse mode |
| Image Detector | Image Intensifier |
| Voxel Size | 6": 0.1667mm |
| 4": 0.1111mm | |
| Camera Pixel | 1004(H) x 1004(V) |
| Image Acquistion | 220° |
| Exposure time | 10sec |
| Scan time | 20sec |
| Image reconstruction time | 3 min |
| Reconstruction type | Cone beam |
| Focal spot size (small) | 0.5mm |
| Total filtration | 2.8mm Al equivalent |
| (inherent filtration 0.8mmAl) | |
| Source to skin distance | 200mm |
| Main unit Dimensions (mm) | 1500 X 1750 X 1950 |
| Total weight | 220kg |
2
6. Indications for use
The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support. VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.
7. Safety and Effectiveness, comparison to Predicate
The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
APR 2 6 2010
GENORAY Co., Ltd. % Mr. Jae Kim Business Development Manager GENORAY America, Inc. · 1073 N. Batavia St. ORANGE CA 92867
Re: K092171
Trade/Device Name: Digital Extraoral Source X-Ray System (Models: VOLUX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 23, 2010 Received: March 24, 2010
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
4
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,
Donald J. Trump
Donald J. St Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for use Exhibit 4
510(k) number (if known): K 092171
Device Name: Digital Extraoral Source X-Ray System (Models: VOLUX)
Indications for Use:
The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support.
VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.
Prescription Use > (Part 21 CFR 801 Subpari 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 Deviee Exaluation (ODE) ODE) OF 1
Robert Beckerf
(Division Sign-Off)
Division of Radiological Devices/
Office of In
510K K092 N1
GENORAY Co., Ltd.