DVT SCANNER

K051980 · Imaging Sciences Intl., Inc. · JAK · Aug 19, 2005 · Radiology

Device Facts

• Record ID: K051980
• Device Name: DVT SCANNER
• Applicant: Imaging Sciences Intl., Inc.
• Product Code: JAK · Radiology
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The DVT Scanner is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

Device Story

DVT Scanner is a dedicated X-ray imaging device; acquires 360-degree rotational X-ray sequence via motorized gantry; reconstructs 3D volume from 2D images; produces 2D cross-sections and 3D views. Operated by dentists, oral surgeons, or physicians in clinical settings. Software processes acquired images, displays them on workstation monitor. Clinicians use output for diagnostic visualization and measurements (e.g., implant planning, TMJ assessment). Benefits include high-contrast 3D anatomical information for surgical planning and diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dedicated X-ray imaging system; motorized gantry with X-ray source and image detector; 360-degree rotational acquisition; workstation-based image reconstruction and display; connectivity for printing or export to magnetic/optical media.

Indications for Use

Indicated for dentists, oral surgeons, and physicians requiring 3D imaging of high-contrast objects, including TMJ studies, mandible and maxilla for implant planning, sinuses, maxillofacial complex, and temporal bone.

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.

Predicate Devices

• NewTom QR - DVT 900 (K003787)
• Advantage 3-D XR (K945375)
• 3D Accu-l-tomo XYZ Slice View Tomograph (K030450)

Submission Summary (Full Text)

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K05/980

AUG 1 9 2005

## 510 (k) Summary

Submitters Information

Name:

Address:

Phone Number:

Fax Number:

Person To Contact:

-Date Of Summary:

Trade Name Of The Device:

Common Or Usual Name:

Classification Name:

Imaging Sciences International Inc.

1910 North Penn Road Hatfield PA, 19440

215-997-5666

215-997-5665

David W. Cowan Vice President of Engineering, Quality Assurance and Government Compliance

July 20, 2005

DVT Scanner

Computed Tomography X-ray System

Computed Tomography X-ray System

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Substantial Equivalence Claim: The Imaging Sciences International Inc. DVT Scanner is substantially equivalent to the devices listed below:

| <b>Device:</b> | NewTom QR - DVT 900 |
|------------------------|-----------------------------------------------------------------------------------------|
| <b>Manufacturer:</b> | NIM s.r.1.<br>Via Silverstrini, 20<br>37135 Verona<br>Italy |
| <b>510 (k) Number:</b> | K003787 |
| <b>Device:</b> | Advantage 3-D XR |
| <b>Manufacturer:</b> | General Electric Medical Systems<br>283, rue de la Miniere<br>78533 Buc Cedex<br>France |
| <b>510 (k) Number:</b> | K945375 |
| <b>Device:</b> | 3D Accu-l-tomo XYZ Slice View Tomograph |
| <b>Manufacturer:</b> | J. Morita Manufacturing Corporation<br>680 Higashihama Minami-cho, Fushimi-ku<br>Japan |
| <b>510 (k) Number:</b> | K030450 |

Description Of The Device: The DVT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional that aod a boo adgrounde and produces two dimensional views of this volume. The matix of the oxamined stances and thickness on two dimensional images. Images produced by the DVT Scanner can be printed or exported on magnetic and optical media.

The DVT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, sonward. The bormal images and displays them on the workstation monitor for viewing.

Intended Use Of The Device: The DVT Scanner is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is or other primaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

Comparison with Predicate Devices: The DVT Scanner reconstructs a three dimensional model from X-ray images similar to the model obtained using the predicate

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devices. It displays either two-dimensional cross-sections or three dimensional views and allows the user to take measurements on reconstructed images.

Conclusions: The DVT Scanner Acquires an X-ray rotational sequence and provides and three-dimensional information on the analyzed volume. The potential hazards (e.g. tiffee-umlensional information on the interest measurements or misdiagnosis) are elcontrolled by the design development, verification and validation process which includes a risk management system.

The DVT Scanner complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the circle is a stylized image of an eagle with three curved lines representing its wings and body. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 9 2005

Mr. Dave Cowan Vice President of Engineering, Quality Assurance and Government Compliance Imaging Sciences International, Inc. 1910 North Penn Road HATFIELD PA 19440

Re: K051980 Trade/Device Name: DVT Scanner Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: JAK Dated: July 20, 2005 Received: July 27, 2005

### Dear Mr. Cowan:

Dour Nr. Overally we have reviewed your becally broths) preisantially equivalent (for the indications for use stated in above and have decemined the as reedicate devices marketed in interstate commerce prior to the cherosate) to tegary mancess presional Device Amendments, or to devices that have been May 20, 1770, the chaomient acts 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general economic 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 If your device is classified (500 acon additional controls. Existing major regulations affecting your Apployal), it they oc sabject to between 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 I teast of advisou that i 27 rion that your device complies with other requirements of the Act or any I DA nas made a acteriminations administered by other Federal agencies. You must comply with all the r caral surves and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, invidenty, between gractice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic 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)
The States of the Research Figure freebotential equivalence of your device to a This letter will allow you to begin maketing your as assence of your device of your device to a legally
premarket notification. The FDA inn has if seus device and this perm premarket notification. The FDA Inding of Substantial or your device and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 Clik Parl 801), please
s and the success on and commend the following numbers, based on the reg If you desire specific advice for your device on our labering regulation (
contact the Office of Compliance at one-of the following numbers, based and the regulation number a the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other geherar information on your respendential.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) DIVISION of Small Manass97 or at its Internet address 038-2041 of (2017) 145-0577 175-05-2017 01:11:11 PM ...
http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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Kos 1980

## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

2x - 4

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The Imaging Sciences International Inc. DVT Scanner constructs multations For Goe. The images taken during a rotational X-ray sequence. The a thickslonal model from the med whenever a dentist, oral surgeon, or other DVT Scanner is mendou to be assur high contrast objects. The DVT Scanner is optimized physician necus 3D information of mgilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

Prescription Use × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

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

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