NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM

K072357 · Afp Imaging Corp. · MUH · Sep 18, 2007 · Dental

Device Facts

• Record ID: K072357
• Device Name: NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Applicant: Afp Imaging Corp.
• Product Code: MUH · Dental
• Decision Date: Sep 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The NewTom VG is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

Device Story

NewTom VG is a dedicated X-ray imaging system for dento-maxillofacial applications. Device acquires 360-degree rotational X-ray sequences using a motorized arm, X-ray source, and flat panel detector. System reconstructs a 3D matrix of the examined volume from the acquired images. Output includes 2D views and 3D renderings displayed on an x86-based workstation. Clinicians use the system for diagnostic support, surgical planning, and monitoring of dental implantations. Hardware allows for patient imaging in both sitting and standing positions. Output enables distance and thickness measurements on 2D images, aiding clinical decision-making regarding bone morphology and surgical intervention.

Clinical Evidence

Bench testing only. Verification and validation testing, including electrical safety and EMC/EMI testing, were performed to support hardware and software modifications. No clinical data provided.

Technological Characteristics

Dedicated X-ray imaging system; X-ray source, flat panel detector, motorized arm, and control box. Operates on x86 architecture workstation. Supports sitting and standing patient positions. Connectivity via magnetic/optical media export. Software-based 3D reconstruction from 360-degree rotational X-ray sequence.

Indications for Use

Indicated for diagnostic imaging support in dento-maxillofacial radiology and maxillofacial surgery. Used for planning and monitoring of implantations and bone morphology analysis of the maxillofacial region.

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

• NewTom 3G Computed Tomography X-Ray System (K041137)

Submission Summary (Full Text)

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K072357

SEP | 8 2007

# Special 510(k) Summary for NewTom VG Computed Tomography X-Ray System

#### 1. SPONSOR

AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523

Phone: [phone] Fax: [phone]

Contact Person: David Vozick Telephone: [phone] ext. 204

Date Prepared: August 21, 2007

#### 2. DEVICE NAME

| Proprietary Name: | NewTom VG Computed Tomography X-Ray System |
|----------------------|--------------------------------------------|
| Common/Usual Name: | X-Ray System |
| Classification Name: | Computed Tomography X-Ray System |

#### 3. PREDICATE DEVICES

NewTom 3G Computed Tomography X-Ray System K041137

#### 4. DEVICE DESCRIPTION

The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.

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The NewTom VG is designed for use in diagnostic support both in dento-maxillofacial radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.

The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).

#### న్. INTENDED USE

The NewTom VG is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The technological characteristics of the NewTom Computed Tomography X-ray System and the parent NewTom 3G Computed Tomography X-ray Systems are substantially equivalent in that they are devices designed to provide images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The proposed NewTom VG and the parent NewTom 3G are computer controlled dedicated x-ray imaging devices that construct three-dimensional models from images taken during a rotational x-ray sequence. It is optimized for bone morphology analysis of the maxillofacial region.

The proposed NewTom VG and the NewTom 3G both use an X-ray imaging system that acquires a 360 degrees rotational x-ray sequence and reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images.

The proposed NewTom VG hardware, including a control box and framework comprised of an x-ray source, detector and either a fixed or rotating arm whereas the NewTom 3G system consists of the same components with only a fixed arm. The

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proposed NewTom VG allows imaging to be performed in both a sitting and standing position and the parent NewTom 3G system only allows imaging to be performed in a supine position. The above differences do not impact safety or effectiveness since both the parent NewTom 3G and the proposed NewTom VG system are identical in that they are computer controlled dedicated x-ray imaging devices that constructs threedimensional models from images taken during a rotational x-ray sequence. The technological characteristics for both the proposed NewTom VG and the parent NewTom 3G devices provide the user with a method of constructing a threedimensional models from images taken during a rotational x-ray sequence. Therefore, the addition of hardware to improve image quality and flexibility of design represent minor technological differences that do not affect the overall safety or effectiveness of the proposed NewTom VG Computed Tomography X-ray System.

#### 7. Performance Testing

Electrical safety, EMC/EMI testing, and verification and validation testing were performed to support the hardware and software modifications. The NewTom VG Computed Tomography X-Ray System met all requirements, and functioned as intended and is therefore safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "OF HEALTH & HUMAN SERVICES USA" written around the perimeter of the circle. Inside the circle is a symbol that appears to be three stylized lines that resemble a bird in flight. The logo is black and white and has a simple, clean design.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## SEP 1 8 2007

AFP Imaging Corporation % Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants. Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K072357

Trade/Device Name: NewTom VG Computer Tomography X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 21, 2007 Received: August 22, 2007

### Dear Ms. McNamra-Cullinane:

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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a stylized font. Below the letters, the word "Centennial" is written in cursive. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.

Prossing and Promoting Publio Hoalth

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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

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: NewTom VG Computed Tomography X-ray System

Indications for Use:

The NewTom VG Computed Tomography X-ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) প্লফ্ল্

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hels Perman

(Division Sign-Off)

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