PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).

K070664 · Progeny, Inc. · MUH · Apr 26, 2007 · Dental

Device Facts

• Record ID: K070664
• Device Name: PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
• Applicant: Progeny, Inc.
• Product Code: MUH · Dental
• Decision Date: Apr 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.

Device Story

Progeny Imaging Software is a diagnostic display system for digitally acquired dental x-ray images and intraoral video camera feeds. Used in dental clinics by dental professionals; software runs on PC platforms (Windows XP). Device functions as a viewer for radiographic data; facilitates clinical visualization of dental anatomy. Output allows healthcare providers to review images for diagnostic purposes, supporting clinical decision-making in dental procedures. Benefits include improved visualization of dental diagnostic images.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through bench testing, software verification and validation, and hazard/risk analysis.

Technological Characteristics

Software-only diagnostic display system. Operates on PC hardware (Windows XP). Supports USB and Ethernet connectivity. Displays dental x-rays and intraoral video images. SVGA display resolution.

Indications for Use

Indicated for display of intraoral radiographic images in dental radiography for 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

• Gendex Vix Win Pro (K060178)
• Schick CDR software (K022953)

Submission Summary (Full Text)

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K070664

## 510(k) Summary

APR 26 2007

as required by CFR section 807.92(c)

### I. General Information

March 1, 2007 Date:

Applicant: Progeny, Inc. 1807 Barclay Blvd. Buffalo Grove, III. 60089

Alan Krema Contact Person:

847-850-3800 x785 Telephone:

847-850-3800 Fax:

#### II. Names

Device Name:

PROGENY IMAGING SOFTWARE Trade Name: Common Name: Exra Oral X-Ray System Classification Name: 90 MUH Extra oral source x-ray system

#### III. Predicate Devices

Gendex Vix Win Pro Schick CDR software

#### IV. Product Description

The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.

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## V. Indications for Use / Rationale for Substantial Equivalence

The Progeny Imaging Software is to be used as a display of intraoral radiographic images in Dental radiography.

The Progeny Imaging Software shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.

There are several major independent manufacturers of Intra Oral diagnostic Radiographic software display systems on the U.S. market. One is the Gendex Vix Win Pro. The 510(k) number is K060178 . The classification of the Dentsply device is listed as product code 90 MUH.

Another currently marketed device is the Schick CDR software, manufactured by Schick, Inc. The 510(k) number is K022953. The classification of the Schick CDR is listed as product code 90 MUH .

| Comparison Table: | | | |
|--------------------|--------------------------------------|-------------------------------------|-------------------------------------|
| Characteristic | Vix Win Pro | CDR | Progeny Imaging |
| | K060178 | K022953 | |
| Implementation | Software Only | Software and Sensor | Software Only |
| Computer | PC | PC | PC |
| Operating System | Windows 98,<br>2000, & XP | Windows 98,<br>2000, XP | Windows XP |
| Display Resolution | 1024 x 768 true color<br>recommended | | SVGA |
| USB support | Yes | Yes | Yes |
| Ethernet support | No | No | Yes |
| Images Displayed | Dental x-rays,<br>Intra oral images | Dental X-rays,<br>Intra oral images | Dental x-rays,<br>intra oral images |

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#### VI. Safety and Effectiveness Information

Safety and effectiveness is demonstrated by:

Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.

All of the above steps and evaluations combine to demonstrate that the Progeny Imaging Intraoral Dental X-Ray Software is safe and effective when the device is used as labelled.

#### VII. Conclusion

The Progeny, Inc. Progeny Imaging Software is determined to be substantially equivalent to the predicate devices, the Gendex Vix Win Pro, and the Schick CDR software. The Progeny Imaging software shares the same indications for use, materials, design, operational and functional features to the currently marked predicate devices listed in section III of this summary. The Progeny Imaging software is safe and effective when the device is used as labelled.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol consisting of three curved lines that resemble human figures or waves. The text "DEPARTMENT OF HEALTH & HU" is arranged vertically along the left side of the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089

APR 2 6 2007

Re: K070664

Trade/Device Name: Progeny Imaging software Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 28, 2007 Received: March 9, 2007

Dear Mr. Krema:

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 shows a circular logo with the text "1906-2006" at the top. Below the text is a stylized "FDA" in bold letters. The word "Centennial" is written in a cursive font below the FDA letters. There are four stars at the bottom of the logo.

Protesting and Promoting Public Health

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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/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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KM0664

# Statement of Indications for Use:

K070664

Intended Use for the Progeny Imaging software:

The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.

*Prescription Use*

Daniel G. Bergman

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