APEX HRI DIGITAL RADIOGRAPHY SYSTEM

K023292 · Krugman Technologies, Inc. · MUH · Dec 13, 2002 · Dental

Device Facts

• Record ID: K023292
• Device Name: APEX HRI DIGITAL RADIOGRAPHY SYSTEM
• Applicant: Krugman Technologies, Inc.
• Product Code: MUH · Dental
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

This device is used to take dental intraoral diagnostic xrays

Device Story

Apex HRI Digital Radiography System captures dental intraoral X-ray images; replaces traditional film/chemicals. Sensor, covered in sterile disposable sheath, placed in oral cavity; external X-ray tube emits radiation detected by sensor. Sensor transmits data stream to connected computer; imaging software interprets data, displaying grayscale image on monitor for dentist. Used in dental clinics by dental professionals for diagnostic purposes; facilitates immediate digital visualization of dental structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate devices.

Technological Characteristics

Intraoral digital X-ray sensor; CCD sensor technology; manufactured by Fimet Oy. Uses sterile disposable barrier sheaths for infection control. Connects to computer system for data transmission and image processing.

Indications for Use

Indicated for dental patients requiring intraoral diagnostic x-rays, replacing standard film and chemical development in dental practices.

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 Radiologie RVG Portable Radiovisiography (K950532)
• Mediadent HDXMMD HDX SP xray sensor (K002425)
• Computed Oral Radiology System (K933455)

Submission Summary (Full Text)

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# igman Technologies. In

September 24, 2002

# DEC 1 3 2002

## 510 (k) Summary

K023292

#### Submitter Information:

Krugman Technologies, Inc. 1000 Hart Road Suite 180 Barrington, IL 60010 Phone: [phone] [phone] Fax: Email: [e-mail]

#### Name of Device:

Trade Name: Apex HRI Digital Radiography System Common Name: Intraoral Digital Xray sensor Classification Name: Unit, Xray, Intraoral (per 21 CFR Section 892.1800) This is a Class II device MUH

Product Code:

#### Substantially Equivalent Devices:

Trophy Radiologie RVG Portable Radiovisiography K950532 Mediadent HDXMMD HDX SP xray sensor K002425 Computed Oral Radiology System K933455

#### Device Description:

Digital dental Intraoral Xray sensor

#### Intended Use:

This device is used to take dental intraoral diagnostic xrays

#### Technological Characteristics compared to predicate devices:

The Apex HRI Digital Radiography sensor is identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product manufacturer for the Apex and Mediadent devices is Fimet Oy. The Apex HRI Digital Radiography sensor is virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials. The only difference between these and the Computed Oral Radiology System is the type of sensor employed. The Computed Oral Radiolology System uses a CMOS sensor while Apex, Mediadent and Trophy use a CCD sensor. This is a minor difference in design. All four products are used in exactly the same manner and circumstances. All four use the same barrier protection for infection control as well.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 13 2002

Mr. Michael A. Krugman President Krugman Technologies, Inc. 1000 Hart Road. Suite 180 BARRINGTON IL 60010

Re: K023292 Trade/Device Name: Apex HRI Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: September 24, 2002 Received: October 2, 2002

#### Dear Mr. Krugman:

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 (PMA), it may be subject to 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.

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

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.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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# Krugman Technologies, Inc.

September 24, 2002

### Indication for Use

510 (k) Number: KO23292 Device Name: Apex HRI Digital Radiography System

The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.

The Apex HRI Digital Xray Sensor is covered with a sterile disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to xray. The dental xray tube (which is NOT part of this product) is pointed at the sensor and activated.

The emitted radiation from the xray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. The inaging software interprets the data stream and displays it as a grey scale image on the monitor of the connected computer system. The grey scale image is the digitally formed xray the dentist will then use for diagnostics.

David A. Dunn

on Sign-Off) of Reproductive, Ab ominal diclogical Devic : Xky Number

Prescription Use

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