MODIFICATION TO DIGIPAN

K991912 · Trophy Radiologie · EHD · Jun 22, 1999 · Dental

Device Facts

• Record ID: K991912
• Device Name: MODIFICATION TO DIGIPAN
• Applicant: Trophy Radiologie
• Product Code: EHD · Dental
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units : OP100, manufacturer Instrumentarium, K912893; OrthoSlice OS1000, manufacturer ASAHI, K991455 pending; Panoura Ultra, manufacturer YOSHIDA, K number unknown to us; X-Caliber, manufacturer ASAHI, K number unknown to us. The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referal copies of the image can be obtained with optional hard copy systems.

Device Story

DIGIPAN is a digital imaging kit designed to retrofit existing panoramic X-ray units (OP100, OrthoSlice OS1000, Panoura Ultra, X-Caliber). The device captures X-ray signals, converts them into digital images, and displays them on a computer monitor for primary diagnostic use by clinicians. The system enables digital archiving of images and supports optional hard copy printing. It functions as a replacement for conventional film-based radiography in dental or clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Digital imaging kit for panoramic X-ray units; interfaces with existing X-ray hardware to capture and digitize radiographic signals; output displayed on computer monitor; supports digital storage and archival.

Indications for Use

Indicated for use as a digital imaging kit for panoramic X-ray units to generate, display, and archive diagnostic images, replacing conventional film 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.

Predicate Devices

• DIGIPAN (K961826)

Reference Devices

• OP100 (K912893)
• OrthoSlice OS1000 (K991455)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1999

Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy Radiologie 4 rue F. Pelloutier Croissy Beaubourg 77437 Marne la Vallee Cedex, 2 FRANCE

Re:

K991912 DIGIPAN Digital Kit for Panoramic X-Ray Dated: June 3, 1999 Received: June 7, 1999 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Ms. Marie-Pierre Labat-Camy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel C. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/0/Picture/15 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

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Image /page/1/Picture/1 description: The image shows the logo for Trophy Rex Group. The logo features a stylized letter 't' with a circle above it, followed by the word 'trophy' in a bold, sans-serif font. Below 'trophy' is 'REX Group', with 'REX' in a larger, bolder font than 'Group'.

510 (k) Number : K961826

## Device Name : DIGIPAN

## Indication For Use :

The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units :

| OP100, | manufacturer Instrumentarium, | K912893 |
|--------------------|-------------------------------|------------------------|
| OrthoSlice OS1000, | manufacturer ASAHI, | K991455 pending |
| Panoura Ultra, | manufacturer YOSHIDA, | K number unknown to us |
| X-Caliber, | manufacturer ASAHI, | K number unknown to us |

The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referal copies of the image can be obtained with optional hard copy systems.

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF needed )

Concurence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram
Division Sign Off

Division Sign-Off sion of Reproductive, Abdominal, ENT d Radiological Dev

510(k) Number 991912

Prescription Use
( Per 21 CFR 801.109 )

or

Over-The-Counter Use ( Optional Format 1-2-96)