(78 days)
No
The summary describes standard medical image processing and visualization software without mentioning AI or ML capabilities.
No
The device is described as imaging software intended for diagnosis, not for treating or alleviating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis." The "Device Description" also mentions providing functions "for further rapid and precise diagnosis." This direct mention of "diagnosis" indicates that the device aids in the diagnostic process.
Yes
The device is explicitly described as a "software package" and "computer based dental imaging software" that processes images obtained from external hardware (CT, X-ray systems). It does not include or rely on any proprietary hardware components for its core functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Triana's Function: Triana's intended use and device description clearly state that it processes and analyzes medical images obtained from imaging modalities like CT and X-ray systems. It provides visualization and analysis tools for diagnosis based on these images.
- No Sample Analysis: There is no mention of Triana analyzing biological samples or performing tests on bodily fluids or tissues. Its function is solely focused on the processing and interpretation of medical images.
Therefore, Triana falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Triana is intended for use as a software package which obtains medical images from CT, Cephalometric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Product codes
LLZ
Device Description
Triana is a computer based dental imaging software which obtains medical images taken from CT, Cephalometric / Panoramic X-ray system & etc. and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Triana is designed to provide users easy and familiar user-interface. Also Triana makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with rendering functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, Cephalometric / Panoramic X-ray system
Anatomical Site
Not Found
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
The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K103/82
JAN 1 4 2011
Picture archiving and communications system / Model: Triana
- Company and Correspondent making the submission l.
- 1.1 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.: +82-31-740-4100 Fax: +82-31-737-8025
- 1.2 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: jae@genoray.com
-
- Establishment Registration Number 3005843418
3. Device Information
Proprietary / Trade Name:
Common / Usual Name: Classification Name: Product Code: LLZ Device Class:
Picture archiving and communications system / Model: Triana Picture archiving and communications system System, Image Processing, Radiological
Class II per regulation 21 CFR 892.2050
-
- Equivalent Legally Marketed Device
Manufacturer: CyberMed, Inc. Device Name: OnDemand3D K070464 (Decision Date - March 16, 2007) 510(k) Number: System, Image Processing, Radiological: LLZ, Classification: Class II per regulation 21 CFR 892.2050
- Equivalent Legally Marketed Device
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5. Description of the Device
Triana is a computer based dental imaging software which obtains medical images taken from CT, Cephalometric / Panoramic X-ray system & etc. and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Triana is designed to provide users easy and familiar user-interface. Also Triana makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with rendering functions.
6. Indications for use
Triana is intended for use as a software package which obtains medical images from CT, Cephalometric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Safety and Effectiveness, comparison to Predicate 7.
Triana, which is made by GENORAY Co., Ltd., is substantially equivalent to Ondemand3D of CyberMed, Inc. We selected the Ondemand3D as the predicate device already CE & FDA approved. Because of Ondemand3D and Triana are almost same in function & characteristic. Triana & OnDemand3D are intended for use as PACS software which obtains medical images from modality. And, these store images and provide 3D visualization and 2D analysis, various MPR functions for further rapid and precise diagnosis. The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
8. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 GENORAY Co., Ltd., concludes that the Picture archiving and communications system (Model: Triana) is safe and effective and substantially equivalent to the predicate device as described above.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three parallel lines curving upwards, resembling a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GENORA Y Co., Ltd. % Mr. Jae Kim Business Development Manager 1073 N. Batavia St. ORANGE CA 92867
JAN 1 4 2011
Re: K103182
Trade/Device Name: Picture archiving and communications system (Models: Triana) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2010 Received: October 28, 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
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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 (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,
Signature
David G. Brown. Ph.D. 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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510(k) number (if known): K103182
JAN 14 2011
Device Name: Picture archiving and communications system (Models: Triana)
Indications for Use:
Triana is intended for use as a software package which obtains medical images from CT, Cephalometric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
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)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103182