(190 days)
No
The summary does not mention AI, ML, or any related terms, and the described functions are standard for dental imaging software.
No
This device is for acquiring, storing, displaying, and manipulating dental images for viewing, diagnostic, and administrative purposes, not for treating or preventing a disease.
Yes
The description explicitly states "Viewing and manipulation for diagnostic purposes" under both "Intended Use / Indications for Use" and "Device Description."
Unknown
The summary describes software functionalities for dental image handling and viewing but does not explicitly state that the device is only software. It mentions "Acquiring and handling of radiographs and color images," which could potentially involve hardware components for image acquisition, although the focus is on the software aspects of viewing and manipulation. Without a clear statement confirming it is software-only, it's not possible to definitively classify it as such based solely on this summary.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is for acquiring, storing, displaying, and manipulating dental images, specifically radiographs and color images of teeth and surrounding structures. These are images of the body, not specimens derived from the body.
- The intended uses are focused on image handling, viewing, and manipulation for various dental purposes. While one of the uses is "Viewing and manipulation for diagnostic purposes," this refers to the interpretation of images, not the analysis of biological samples.
The device is a medical device used in the dental field for imaging and image management, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for acquisition, storage, display, and manipulation of Dental Images
Product codes
90 LLZ, 90 MUH
Device Description
Intended uses in the dental industry include the following:
Acquiring and handling of radiographs and color images:
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging. When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are: dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental radiographs and color images
Anatomical Site
Not Found
Indicated Patient Age Range
general public
Intended User / Care Setting
general practitioners and specialists in the dental care field.
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
Testing was performed according to internal company protocols established before testing was conducted. Software testing and validation were done according to which by designated technical professionals before software I est results were results support the conclusion that actual device performance satisfies the design intent.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 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
EXHIBIT 2
FEB 0 6 2002
Radco Data AB Anestagatan 29 SE-163 53 Spånga, SWEDEN Phone (011) 46 (0)8 5221 84 00 Fax (011) 46 (0) 73 920 84 10 Contact: Anders Berggren, President and CEO July 30, 2001
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "DentalEye 2" Dental Image Management System Classification Name: 90 LLZ Common/Usual Name: Dental Image Management System
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- Equivalent legally marketed device: This product is similar in design and identical in function to the TAU TigerView, K955237
-
- Indications for Use (intended use): Indicated for acquisition, storage, display, and manipulation of Dental Images
-
- Description of the device: Intended uses in the dental industry include the following:
Acquiring and handling of radiographs and color images:
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging. When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are: dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.
| Comparison Areas | TAU TigerView, K955237 | "DentalEye 2" Dental Image Management System |
|---|---|---|
| Indications for use | Indicated for acquisition, storage, display, and manipulation of Dental Images | SAME |
| Host platform | Standard PC platform with Windows NT | SAME, can also use Windows 95, 98, and 2000 |
| Video capture | Matrox Meteor II | Studio PCTV |
| Receive images from other systems | YES | SAME |
-
- Safety and Effectiveness, comparison to predicate device:
1
-
- Testing information and Conclusion
r ssting information and Ochelable: "
In all material respects, the "DentalEye 2" Dental Image Management System is In an material respocts, and Tiger View, K955237. Testing was performed substantially equirtations procedures. Software testing and validation were according to internal company protocols established before testing was conducted. done according to which by designated technical professionals before software I est results were results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three overlapping shapes that resemble an abstract caduceus or a bird in flight. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
DentalEve AB % Mr. Daniel Kamm P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K012439
Trade/Device Name: DentalEye 2, Dental Image Management System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: December 11, 2001 Received: December 12, 2001
Dear Mr. Kamm:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050,
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Drice 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 Part 801), please If you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally) , 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of relocution to promazive the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number
5 ro(if) Names.
Acquiring and handling of dental radiographs and color images Viewing and manipulation for insurance claims adjudication. Viewing and manipulation for diagnostic purposes Viewing for patient education and consultation including cosmetic imaging.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻬﻢ ﻓﻲ ﺍﻟﻤﺮﺍﺟﻊ Prescription Use_
Over the Counter Use_ OR (Per 21 CFR 801.109)
David G. Leggott
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number