(137 days)
The Trophy Radiologie digital imaging kit, DIGIPAN, can replace the conventional film for primary diagnostic purpose. The image generated is displayed on a computer monitor. The image can then be archived through computer storage and archival means. Referral copies of the image can be obtained with optional hard copy systems.
DIGIPAN/DPI Digital Kit for Panoramic X-ray Device
This document is a 510(k) clearance letter from the FDA for the Trophy Radiologie DIGIPAN/DPI Digital Kit for Panoramic X-ray Device, dated December 21, 2001. It is a clearance for market, based on substantial equivalence to a predicate device.
The document does not contain information about acceptance criteria, device performance, sample sizes used for testing, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or training set details.
The letter explicitly states: "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 for associated in the encience of 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)." This means the device met the criteria for substantial equivalence to an existing device, rather than going through a de novo review that would typically involve establishing new acceptance criteria and conducting detailed performance studies against those criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
Mr. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy Radiologie 4 rue F. Pelloutier Croissy Beaubourg 77437 Marne-la-vallée CEDEX 2, FRANCE
Re: K012514
Trade/Device Name: DIGIPAN/DPI Digital Kit for Panoramic X-ray Device Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: October 4, 2001 Received: October 9, 2001
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 for associated in the encience of 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.
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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 vours.
Vancy C. Snogdin
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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October 4, 2001
Image /page/2/Picture/2 description: The image shows the logo for Trophy TREX Group. The logo features a stylized letter 'T' with a circle above it, followed by the word 'rophy' in a bold, serif font. Below 'rophy' is 'TREX' in a bold, sans-serif font, and to the right of 'TREX' is the word 'Group' in a smaller font.
DEC 2 1 2001
510 (k) Number : K012514
DIGIPAN Device Name :
Indication For Use :
The Trophy Radiologie digital imaging kit, DIGIPAN, can replace the conventional film for primary diagnostic purpose.
primary anaghosite purposited on a computer monitor.
The image generated is displayed on a computer monitor.
The image generated is alsplayed on a computer storage and archival means. Referral
The image can then be archived through computer storage and archival measureme I he image can then be arentred with optional hard copy systems. copies of the image can be oblained with Optional hard copy of the may units according to the attached installation manuals.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurence of CDRH, Office of Device Evaluation (ODE)
David G. Seymon
(Division Sign-Off)
Division of Reproductive, Abdeminel,
and Radiological Devices/
510(k) Number. K0/2514
Prescription Use_ ( Per 21 CFR 801.109 ) or
Over-The-Counter Use_ ( Optional Format 1-2-96)
§ 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.