DIGIPAN / DPI

K012514 · Trophy Radiologie · MUH · Dec 21, 2001 · Dental

Device Facts

• Record ID: K012514
• Device Name: DIGIPAN / DPI
• Applicant: Trophy Radiologie
• Product Code: MUH · Dental
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

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. Optional hard copy of the image can be obtained with optional hard copy systems. The device is intended to be used with panoramic X-ray units according to the attached installation manuals.

Device Story

DIGIPAN is a digital imaging kit designed to retrofit existing panoramic X-ray units; replaces conventional film with digital sensor technology. Input consists of X-ray radiation signals captured during panoramic imaging; device transforms these into digital images for display on a computer monitor. Used in clinical settings by dental or radiological professionals. Output allows for immediate visualization, digital storage, archival, and optional hard-copy printing. Facilitates primary diagnostic assessment by providing digital image access; improves workflow efficiency compared to traditional film processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital imaging kit for panoramic X-ray systems. Consists of a digital sensor, interface electronics, and software for image acquisition and display. Operates as a peripheral to existing X-ray hardware. Connectivity via computer interface for storage and display. Standard clinical environment.

Indications for Use

Indicated for use as a digital imaging replacement for conventional film in panoramic X-ray diagnostic procedures. Intended for use by clinicians for primary diagnostic purposes.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)