CDMX-H

K053221 · Camsight Co., Inc. · MUH · Jan 12, 2006 · Dental

Device Facts

• Record ID: K053221
• Device Name: CDMX-H
• Applicant: Camsight Co., Inc.
• Product Code: MUH · Dental
• Decision Date: Jan 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.

Device Story

CDMx-H is an extraoral source x-ray system for dental diagnostics. Device captures dental x-ray images via digital sensor; processes and displays images for clinician review. Used in dental clinics by dental professionals. Output assists in diagnosis of teeth, jaw, and oral structures. Benefits include digital visualization of oral anatomy for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral source x-ray system; digital x-ray sensor input; Class II device; Product Code MUH; 21 CFR 872.1800.

Indications for Use

Indicated for dental radiographic examination and diagnosis of teeth, jaw, and oral structures in patients requiring dental imaging. Prescription use only.

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

Mr. Jay Choi Director, Regulatory Affairs Camsight Co., Inc. 3380 San Fernando Road LOS ANGELES CA 90065

Re: K053221

JAN 1 2 2006

Trade/Device Name: CDMx-H Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 14, 2005 Received: November 23, 2005

Dear Mr. Choi:

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 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) 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 (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 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 clectronic 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 Section 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 n you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Nancy C. Higdon

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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510(k) number (if known):

page _1_ of _1

Device Name: CDMx-H

Indications For Use:

The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.

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

Concurrent of DCRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Davide Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_