EDLEN IMAGING - GEMINI DUSB

K103290 · Edlen Imaging, LLC · MUH · Sep 19, 2011 · Dental

Device Facts

• Record ID: K103290
• Device Name: EDLEN IMAGING - GEMINI DUSB
• Applicant: Edlen Imaging, LLC
• Product Code: MUH · Dental
• Decision Date: Sep 19, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Edlen Imaging's Gemini DUSB sensor is a USB-driven digital X-ray sensor that acquires dental intra-oral X-ray images. The sensor will be operated by trained dental and related healthcare professionals to acquire dental intra-oral radiographs. The Gemini sensor can be used either in combination with special positioning devices, to facilitate alignment with the x-ray beam, or it may also be positioned manually.

Device Story

Gemini DUSB is an indirect light-converting digital X-ray detector for dental intra-oral imaging. Device uses a scintillating material (e.g., Cesium Iodide) to convert incident X-rays into visible light, which is captured by a CMOS-based light detection imager. Sensor features automatic X-ray detection to generate digital data. Device connects via USB 2.0 to PCs or laptops. Operated by dentists, radiologists, or dental assistants in clinical settings. System integrates with third-party software (Apteryx XrayVision) to display, process, and manage images. Healthcare providers use displayed images to assist in clinical decision-making and diagnosis. Benefits include digital image acquisition, eliminating traditional film processing.

Clinical Evidence

Bench testing only. Device tested for compliance with international safety standards (IEC 60601-1). No clinical data provided.

Technological Characteristics

Indirect conversion digital X-ray detector; Scintillator: Cesium Iodide (CsI); Imager: CMOS technology; Connectivity: USB 2.0; Form factor: Intraoral sensor; Safety standards: IEC 60601-1.

Indications for Use

Indicated for dental intra-oral radiographic imaging. Intended for use by trained dental professionals and healthcare providers to acquire radiographs for diagnostic purposes.

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

• Schick Technologies CDR (K072134)
• Suni Medical Imaging, Inc. Suni Ray II (K070219)

Reference Devices

• Apteryx XrayVision (K983111)

Submission Summary (Full Text)

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x ((0329) D
Edlen Imaging, LLC 3707 North 7th Street, Suite 125

Phoenix, AZ 85014

# 510 (k) Summary

SEP 1 9 2011

As required by CFR section 807.92 [c]

# General Description

| Date: | October 11, 2010 |
|--------------------|-------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Edlen Imaging LLC<br>3707 North 7th Street, Ste 125.<br>Phoenix, Arizona, USA 85014 |
| Contact Person: | Felix Hovsepian |
| Telephone: | 1-602-524-9611 |
| e-mail: | [e-mail] |

# Device Names

| Trade Name: | Edlen Imaging - Gemini DUSB | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Gemini Digital X-ray Sensor | |
| Classification Name: | Unit X-ray sensor Intraoral to capture -<br>Extra Oral X-ray source, per 21 CFR 872-<br>1800. Regulatory Class II. Product Code:<br>MUH. | |

# Predicate Devices

| Company | Device Name | K-Number |
|---------------------------|-------------|----------|
| Schick Technologies | CDR | K072134 |
| Suni Medical Imaging, Inc | Suni Ray II | K070219 |

Image /page/0/Picture/11 description: The image shows the logo for Edlen Imaging. The logo consists of a stylized "E" followed by the word "EDLEN" in a bold, sans-serif font. Below "EDLEN" is the word "IMAGING" in a smaller, sans-serif font. The logo is black and white.

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### Product Description

The Gemini sensor is an indirect light converting digital X-ray detector. Incident X-rays are converted to visible light by a scintillating device, (material) such as Csl (Cesium lodide), the light is coupled optically to a light detection imager which is based on CMOS technology.

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The design of the sensor allows for automatic detection of incident X-rays to generate a digital data which when coupled with a software program will display images used for dental intra-oral applications.

The Gemini Digital x-ray sensor supports USB 2.0 Direct connectivity to personal computers and or laptops, hence the name Gemini DUSB.

The Gemini sensors employ built-in dedicated electronics and sensor software driver, to allow connectivity to a variety of software packages. The Gemini sensors are coupled with the currently marketed software, Apteryx XrayVision, K983111.

#### Intended Use of the Device

The Gemini sensor is a dedicated USB-driven device intended to acquire dental intraoral radiographic images. The sensor is operated by Radiologists, Dentists, Dental Assistants and or like healthcare professionals, who are duly trained and competent to both operate the Gemini sensors and take Dental X-ray radiographs. Intra oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the X-ray beam.

#### Technological Characteristics

The Gemini Digital x-ray sensor is to be used as an intraoral receiver of x-ray in Dental radiography.

The Gemini system shares the same indication for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed above.

There are many independent manufacturers of intraoral x-ray dental radiography systems in the US today. The first is the CDR system by Schick Technologies (K072134) and the second is the Suni Ray II by Suni Medical Imaging (K070219)

A comparison table for the different systems is available in the section on Substantial Equivalence.

The device has been tested by a third party and found to meet the international safety standards established by the IEC (60601-1), further details available in the section on conformance).

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# Software

The Gemini Digital system is provided with imaging software provided by:

Apteryx, Inc. 334 White Pond Drive, Suite A Akron Ohio 44320 Tel: [phone] K983111 (See Attachment 9)

## Conclusion

Edlen Imaging's Gemini Digital x-ray sensors are substantially equivalent to other legally marketed devices in the United States of America. The Gemini Digital x-ray sensors are as safe, as effective, and performs as well as or better than the predicate devices.

Therefore, the Gemini Digital x-ray sensors are deemed to be substantially equivalent to the predicate devices in intended use and technical characteristics to those of:

- C. SuniRay II Digital Radiographic System marketed by Suni Medical Imaging, Inc.
and

- d. The CDR system marketed by Schick Technologies, Inc

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Image /page/3/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized bird-like symbol in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The bird-like symbol consists of three curved lines that resemble wings or feathers, creating a sense of movement or flight.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Dr. Felix Hoysepian CTO Edlen Imaging, LLC 3707 North 7th Street, Suite 125 PHOENIX AZ 85014

SEP 1 9 201

Re: K103290

Trade/Device Name: Gemini DUSB Digital x-ray Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 15, 2011 Received: August 22, 2011

Dear Dr. Hoysepian:

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. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Viiro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR. Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K103290

Device Name: Gemini DUSB Digital x-ray

Indications for Use:

Edlen Imaging's Gemini DUSB sensor is a USB-driven digital X-ray sensor that acquires dental intra-oral X-ray images. The sensor will be operated by trained dental and related healthcare professionals to acquire dental intra-oral radiographs.

The Gemini sensor can be used either in combination with special positioning devices, to facilitate alignment with the x-ray beam, or it may also be positioned manually.

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 OF NEEDED)

> Concurrence of CDRH, Office of Devic Evaluation (ODE) OIVI

Michael O'Hearn

Office of In Vitro

510K K103290