SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

K983283 · Signet Radiology, Inc. · MUH · Nov 6, 1998 · Dental

Device Facts

• Record ID: K983283
• Device Name: SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
• Applicant: Signet Radiology, Inc.
• Product Code: MUH · Dental
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structure.

Device Story

DXIS is a digital dental radiographic imaging system designed to retrofit existing panoramic X-ray machines. It replaces traditional film cassettes with a digital CCD sensor. The system includes the sensor, interface equipment, and acquisition software installed on a user-supplied computer. Operated by dental professionals, the device captures X-ray signals, converts them to digital images, and provides tools for display, storage, enhancement, and printing. By digitizing the imaging process, it facilitates dental diagnosis and reduces radiation exposure compared to film-based systems. The system is used in clinical dental settings to assist practitioners in evaluating oral structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital X-ray imaging system utilizing a CCD sensor for image acquisition. Includes a computer interface board and proprietary acquisition software. Features include digital image processing, enhancement, storage, and hard copy output. Designed for integration with existing panoramic X-ray systems. Operates as a digital replacement for film cassettes.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure in patients requiring dental 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.

Predicate Devices

• Trophy Digipan (K961826)
• Siemens Orthophos DS (K972312)
• Planmeca Dimax (510(k) # not known)

Submission Summary (Full Text)

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510(k) Summarv for DXIS® Digital X-ray Imaging System

510(k) # K983283

## 1. SPONSOR

Signet Radiology, Inc. 253 Logue Rd. P.O. Box 508 Minto, NB, E0E 1J0 Canada

Contact person: Alex Cetateanu (1)506-327-3931 Telephone:

Date prepared: September 4, 1998

## DEVICE NAME 2.

Proprietary Name: Signet DXIS® Direct X-ray Imaging System Common/Usual Name: Digital x-ray imaging system Classification Name: Extra-oral source x-ray system

## 3. PREDICATE DEVICES

Trophy Digipan (K961826) Siemens Orthophos DS (K972312) Planmeca Dimax (510(k) # not known)

## 4. DEVICE DESCRIPTION

The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structure.

The DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.

#### ડ. INTENDED USE

The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, iaw. and oral structure.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIALLY EQUIVALENCE

The DXIS®, like the predicate devices, provides the ability to display, store, or print digital radiographic images of the teeth, jaw or oral structure. A comparison of the DXIS® and the predicate devices is provided in the table given below.

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| | Comparison | SIGNET<br>Radiology | TROPHY | PLANMECA | SIEMENS |
|-----|-----------------------------------------|--------------------------------|---------------------------------------|---------------------------------|---------------------------------|
| 1. | Trade Name | DXIS | DigiPan | Planmeca<br>Dimax | Orthophos<br>DS |
| 2. | Panoramic Image | YES | YES | YES | YES |
| 3. | X-Ray | YES | YES | YES | YES |
| 4. | Replacement film<br>cassette | YES | YES | YES | YES |
| 5. | Digital processing | YES | YES | YES | YES |
| 6. | Level of X-ray<br>Radiation<br>exposure | Up to 50% | 70% | Information<br>not<br>available | Information<br>not<br>available |
| 7. | Acquisition sensor | CCD<br>DXIS<br>Sensor | CCD<br>Digital<br>Cassette | CCD Digital | CCD Array |
| 8. | Panoramic<br>Acquisition Board | NO | YES | Information<br>not<br>available | Information<br>not<br>available |
| 9. | Panoramic<br>Correlator | YES | NO | Information<br>not<br>available | Information<br>not<br>available |
| 10. | Computer<br>Interface Board | YES | YES | YES | YES |
| 11. | Acquisition<br>Software | DXIS<br>Acquisition<br>Program | Trophy<br>Windows<br>Imaging<br>(TWI) | Information<br>not<br>available | SIDEXIS |
| 12. | Enhancement<br>functions | YES | YES | YES | YES |
| 13. | Digital storage | YES | YES | YES | YES |
| 14. | Hard copy | YES | YES | YES | YES |

# Comparison Table: DXIS® and predicate Devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 10008 NOV

Alex Cetateanu President Signet Radiology, Inc. 253 Logue Road P.O. Box 508 Minto, NB. EOE 1J0 Canada

Re:

K983283 Signet DIXS® Direct Dental X-ray Imaging System Dated: September 15, 1998 Received: September 18, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Cetateanu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 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 and additionally 809.10 for in yrity. diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrividsma/dsmamain.html".

**Sincerely yours,**

Lillian Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: DXIS®

Indications For Use:

THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Syzon

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

Prescription Use X (Per 21 CFR 801.109) Over - The - Counter - Use ___________________________________________________________________________________________________________________________________________________

OR