PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

K011619 · Planmeca Oy · EHD · Jun 29, 2001 · Dental

Device Facts

• Record ID: K011619
• Device Name: PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
• Applicant: Planmeca Oy
• Product Code: EHD · Dental
• Decision Date: Jun 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The ProMax, Panoramic X-ray Imaging System with Cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The images are displayed on a monitor, and different diagnostic features are performed via a computer.

Device Story

ProMax is an extraoral X-ray imaging system with cephalostat; used for dental radiographic examination and diagnosis of teeth, jaw, and oral structures. Device captures X-ray images; data processed via computer; images displayed on monitor for clinician review. System intended for use in clinical settings by dental professionals. Output facilitates diagnosis of oral diseases. Benefits include diagnostic visualization of dental and maxillofacial anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral X-ray source; digital imaging system; computer-based image display and processing; cephalostat configuration.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring extraoral X-ray imaging.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2001

Planmeca Oy % Mr. Bob Pienkowski Planmeca USA Inc. 1250 Greenbriar, Suite A ADDISON IL 60101

Re: K011619

Promax, Panoramic X-Ray Unit with Cephalostat Dated: May 23, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Mr. Pienkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Secuent 210(x) noutcations of truse 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 marketed in meetstale commeted provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recalassified in accordance will the 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 III (Premarket Approval), it may be subject of Charl Read Control If your device is classified (so above) and etals etass affecting your device can be found in the Code of Federal Regulations, to succi additional controls. Existure high regultion assumes compliance with the Current God Manufacturing
Title 21, Parts 800 to 895. A substanialiy equivalent determinat I I tte 21, Facts 600 0 693. A Subsamany System Regulation (QS) for Medical Devices: General regulation (21 CFR Part Practice requirelitents, as set forth in the Quality of Sood and Drug Administration (FDA) will verify such assumptions. Failure 620) and that, through periodic Q mapections, action. In addition, FDA may publish further announcements to comply with the User in the Federal Register. Please note: this response to your premarket notification submission does not concerning your device in the reason. " Teass nown respons 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 I fills letter will allow you to obgally 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 If you desice specific dovice tor your device of Corneliance at [phone]. Additionally, for questions on the promise diagnosity of your devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entined, "Misolanding of tections to premation" (2723 research Manufacturers Assistance at its toll-free number (800) 1638-2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Nancy C. Hogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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510(k) Number (if known):

Device Name:

Indications For Use:

The ProMax, Panoramic X-ray Imaging System with Cephalostat, is an extraoral source X-ray The ProMax, F anonaline X-1ay maging o Jersphic examination and diagnosis of diseases of System, whilen is intended for demal racterial racterial with accessories to fulfil the teent, Jaw, and oral structures: The affiguration the images are displayed on a monitor, and different dragnostic frecas. In argual commynication are performed via a computer.

Helsinki, May 23, 2001

Lars Moring

Regulatory Affairs Manager

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Division Sign-Off) Division Sign-Un)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number