(88 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard digital imaging technology.
No
The device is used for imaging (diagnosis), not for treating a disease or condition.
No.
Explanation: The device is an X-ray system used for imaging, which is a tool for acquiring data, not for making a diagnosis. The diagnostic interpretation would be performed by a healthcare professional using the images provided by the device.
No
The device is described as a "Panoramic Dental X-Ray System," which inherently includes hardware components for generating and capturing X-rays. While it utilizes a digital imaging system (DIGIPAN), the overall system is not software-only.
Based on the provided information, this 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.
- Device Function: The TROPHYPAN Panoramic Dental X-Ray System is an imaging device that uses X-rays to create images of the dento-maxillo-facial area. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "imaging of the dento-maxillo-facial area" using an "external source of X-ray." This is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the TROPHYPAN Panoramic Dental X-Ray System falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.
Product codes
MUH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial area
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)
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 03 2003
Mr. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy Radiologie S.A. 4 rue F. Pelloutier Croissv Beaubourg 77437 Marne-la-Vallée Cedex 2, FRANCE
Re: K023346
Trade/Device Name: TrophyPan Regulation Number: 21 CFR 872,1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: October 4, 2002 Received: October 7, 2002
Dear Mr. Labat-Camy:
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.
1
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 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 Part 801), please contact 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number :
Device Name : TROPHYPAN
Indication For Use :
The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF needed )
Concurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801.109 )
or
Over-The-Counter Use ( Optional Format 1-2-96)
Dana
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number ko23346