BIO-RAY SDX DIGITAL X-RAY SYSTEM

K060179 · Sigma Biomedics, Inc. · MUH · Feb 8, 2006 · Dental

Device Facts

• Record ID: K060179
• Device Name: BIO-RAY SDX DIGITAL X-RAY SYSTEM
• Applicant: Sigma Biomedics, Inc.
• Product Code: MUH · Dental
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the teeth, jaw and oral structures with the use of computer imaging software provided by other 30 parties, readily available from numerous sources. This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors.

Device Story

Bio-Ray SDX is an intraoral digital X-ray sensor; captures dental X-ray images; converts analog X-ray input into electronic data; data stored, viewed, and manipulated via third-party computer imaging software. Used in dental clinics; operated by dentists. Output assists in diagnosis of teeth, jaw, and oral structures. Benefits include digital image acquisition and management for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral digital X-ray sensor; converts X-ray radiation to electronic data; intended for use with standard dental X-ray systems; requires third-party computer imaging software for display and manipulation.

Indications for Use

Indicated for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures. Intended for use by dentists as a prescription device.

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)

{0}------------------------------------------------

FER 8 2006

Image /page/0/Picture/2 description: The image shows the logo for Sigma Biomedics. The logo consists of two hexagons, one filled in black and the other outlined in black. To the right of the hexagons is the text "SIGMA BIOMEDICS" in a sans-serif font. The word "SIGMA" is above the word "BIOMEDICS".

# 510(k) Summary

Sigma Biomedics, Inc. 65 E. Palatine Rd., Blg.#201 Prospect Heights, IL 60070 847-419-0669

Name of Contact person: Kim Antol

Date Summary was prepared: January 9, 2006

#### Name of Device

| Trade/Proprietary Name: | Bio-Ray SDX Digital X-Ray System |
|-------------------------|-----------------------------------------------|
| Common/Usual Name: | Intraoral X-Ray Sensor |
| Classification Name: | Extraoral Source Dental X-Ray, Digital System |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]

### Description of the Device:

Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.

65 E. Palatine Rd., #201, Prospect Heights, 11, 60070, [phone], [phone], Fax-[phone]

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, symbolizing growth and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 2006

2006

Ms. Kim Antol President Sigma Biomedics, Inc. 65 E. Palatine Rd., Bldg. 201 PROSPECT HEIGHTS IL 60070-1845 Re: K060179 Trade/Device Name: BIO-Ray SDX Digital X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 20, 2006 Received: January 24, 2006

Dear Ms. Antol:

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 electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{2}------------------------------------------------

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.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. Brogdon

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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K060179

Device Name: BIO-Ray SDX Digital X-Ray system

#### Indications For Use:

The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.

This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lippman

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

Page I of 1