DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM

K070658 · E-Woo Technology · JAK · Apr 5, 2007 · Radiology

Device Facts

• Record ID: K070658
• Device Name: DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
• Applicant: E-Woo Technology
• Product Code: JAK · Radiology
• Decision Date: Apr 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Story

EPX-Impla is a computed tomography (CT) X-ray system; acquires 360° rotational X-ray sequences of head and neck, including ENT and dentomaxillofacial regions. Operated by physicians, dentists, and X-ray technologists in clinical settings. Provides diagnostic imaging support for clinical decision-making. Benefits include visualization of anatomical structures for dental and ENT diagnostics.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Computed tomography X-ray system; 360° rotational acquisition geometry; intended for head, neck, ENT, and dentomaxillofacial imaging. Class II device (21 CFR 892.1750).

Indications for Use

Indicated for diagnostic support via 360° rotational X-ray imaging of head, neck, ENT, and dentomaxillofacial areas. Intended for use by physicians, dentists, and X-ray technologists.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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APR 5 - 2007

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

E-WOO Technology Co., Ltd. % Mr. Stephen T. Mlcoch President North American Technical Services (NATS) Corp. 30 Northport Road SOUND BEACH NY 11789

Re: K070658

Trade/Device Name: E-WOO Dental Imaging System Model EPX Impla Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 15, 2007 Received: March 9, 2007

Dear Mr. Mlcoch:

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.

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Protecting and Promoting Public Health

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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.

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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

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E-Woo Dental Imaging System Model EPX-Impla 510K Notification

## INDICATIONS FOR USE

510(k) Number (if known):

## KO706 58

Device Name:

Indications for Use:

E-Woo Dental Imaging System Model EPX-Impla

EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ehristha Iverson

Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device

510(k) Number K070658