ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,

K991455 · Trophy Radiologie · EHD · Jun 25, 1999 · Dental

Device Facts

• Record ID: K991455
• Device Name: ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,
• Applicant: Trophy Radiologie
• Product Code: EHD · Dental
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics. The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit. The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit

Device Story

Panoramic dental X-ray system; produces images of dentition, TMJ, and sinus; supports cross-section radiography. Models vary by imaging capability: panoramic, tomographic, and cephalometric. Used in clinical dental and oral surgery settings; operated by trained dental professionals. Device captures X-ray data; software controls imaging process and orbit. Output consists of diagnostic images for clinical review; assists in treatment planning for orthodontics, prosthetics, and implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-controlled diagnostic panoramic dental X-ray equipment. Supports multiple imaging modes: panoramic, tomographic, and cephalometric. System architecture varies by model (OS1000, OS1000E, OS1000C, OS1000EC).

Indications for Use

Indicated for diagnostic panoramic dental x-ray imaging of dentition, TMJ, and sinus; applicable for orthodontic, prosthetic, oral surgery, implant treatment, and otorhinolaryngology applications.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 1999

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

Re:

K991455 Panoramic Orthoslice OS1000 series: OS1000, OS1000E, OS1000EC, OS1000P and OS1000EP Dated: April 12, 1999 Received: April 26, 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 class 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 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

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## 510 (k) NOTIFICATION

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 on its upper right side. Below the 't' is the word "trophy" in a bold, sans-serif font. Underneath "trophy" is the text "REX Group", with "REX" in a bolder font than "Group".

510 (k) Number :

## Device Name : OrthoSlice OS1000, OS1000E, OS1000C, OS1000EC

Indication For Use :

The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible.

Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.

The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit

The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit

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

Concurence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Symm
Division Sign Off

Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use
( Per 21 CFR 801.109 )

Or

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