I-MAX TOUCH

K083057 · Owandy · MUH · Jun 2, 2009 · Dental

Device Facts

• Record ID: K083057
• Device Name: I-MAX TOUCH
• Applicant: Owandy
• Product Code: MUH · Dental
• Decision Date: Jun 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry. It is to be only used by dental practitioners and/or radiologists.

Device Story

I-MAX Touch is an extra-oral digital X-ray acquisition system for dental diagnostics. It captures radiographic images of teeth, TMJ, and cephalometric structures; utilizes a CCD sensor to convert X-ray signals into digital data. System operates in dental clinics; used by dentists or radiologists. Device interfaces with a PC via Ethernet for image review and formatting. Provides various examination programs including standard/reduced-dose panoramic, TMJ, maxillary sinus, and cephalometric views. Clinicians use output images to support diagnostic and treatment planning decisions, such as implant placement. Benefits include high-resolution digital imaging, reduced radiation exposure via optimized programs, and efficient digital storage/retrieval.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extra-oral X-ray system; CCD digital sensor; 86 KVp max; 12 mA max; 2.5 mmAl total filtration; Ethernet connectivity; USB memory storage; Class 1 laser positioning lights (EN60825-1); 500 mm focus-receptor distance.

Indications for Use

Indicated for dental radiographic examination of teeth, including panoramic, TMJ, implantology, and cephalometric studies in patients requiring dental imaging. Used by dental practitioners and radiologists.

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

• STRATO 2000 D (K002432)
• OWANDY digital acquisition device (K041120)

Submission Summary (Full Text)

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OWANDY

I-MAX Touch 510(k)

## 510(K) SUMMARY

Premarket Notification for the I-MAX Touch K083057

JUN – 2 2009

Identification

| Applicant | OWANDY<br>6 Allee Kepler<br>77420 Champs sur Marne - France |
|----------------|-------------------------------------------------------------|
| Contact person | Olivier DEROO, Quality and Regulations Manager |
| Email | [e-mail] |

| TRADE NAME : | I-MAX Touch (PAN and CEPH) |
|------------------|--------------------------------------------------------|
| Common name : | Extra oral source X-Ray System |
| Classification : | according to 21CFR872-1800 , I-MAX Touch is in class 2 |

#### Intended use

The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry.

It is to be only used by dental practitioners and/or radiologists.

#### Substantial equivalence and technological characteristics

The I-MAX Touch is defined as substantially equivalent to the STRATO 2000 D, manufactured by VILLA SISTEMI MEDICALI (X-ray system) and OWANDY (digital acquisition device) and cleared by FDA with K002432 (VILLA) and K041120 (OWANDY). See comparison table in Chapter 3.

The following table compares the two units :

| Trade Name | I-Max Touch | Strato 2000 D |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K083057 | K002432+K041120 |
| Intended use | extra-oral source X-ray system for<br>dental radiographic examination of the<br>teeth and specifically for panoramic<br>examinations, TMJ studies and<br>Cephalometry. | extra-oral source X-ray system for<br>dental radiographic examination of the<br>teeth and specifically for panoramic<br>examinations, TMJ studies,<br>implantology and Cephalometry. |
| CEPH option | Yes | Yes |
| Digital acquisition Sensor | CCD | CCD |
| Computer Interface Board | Ethernet | USB |
| Digital Storage | USB memory stick | Compact flash card |
| High voltage value | 86 KVp max | 80 KVp max |
| Tube current | 12 mA max | 12 mA max |
| Total filtration | 2.5 mmAl | 2.5 mmAl |

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| OWANDY | I-MAX Touch 510(k) | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Examination programs | Adult / Child selection<br>Small / Medium / Large size selection<br>Standard panoramic<br>Right Semi-Panoramic<br>Left Semi-Panoramic<br>Panoramic with improved orthogonality<br>Reduced dose panoramic<br>Incisor block panoramic<br>TMJ<br>Maxillary sinus<br>Lateral Ceph<br>Frontal Ceph<br>Carpus | Adult / Child selection<br>Small / Medium / Large size selection<br>Standard panoramic<br>Right Semi-Panoramic<br>Left Semi-Panoramic<br>Panoramic with improved<br>orthogonality<br>Reduced dose panoramic<br>Incisor block<br>TMJ<br>Maxillary sinus<br>Lateral Ceph<br>Frontal Ceph<br>Carpus |
| X-ray exposure timing | 13,8 Sec PAN adult, CEPH exposure<br>time variable according to the type of<br>resolution and format selected. Max 15<br>sec | 15 Sec PAN adult, CEPH exposure<br>time variable according to the type of<br>resolution and format selected. Max<br>15 sec |
| Electrical characteristics | 6,6 A at 230V 50/60 Hz | 18 A at 110V |
| Positioning lights | Class 1 laser according to EN60825-<br>1+A1+A2 | Class 2 laser |
| Focus receptor distance | 500 mm | 512 mm |
| Minimum room size | 2450X2000X1450 | 2320X1900X1300 |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The symbol is composed of three curved lines that resemble a stylized human form, and it is positioned to the right of the text.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OWANDY

JUN - 2 2009

% Mr. Claude Berthouin Official Correspondent Denterprise International, Inc. RF America, Inc. 110 W. Granada Blvd., Suite 207 ORMOND BEACH FL 32176

Re: K083057

Trade/Device Name: I-Max Touch Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 10, 2009 Received: April 13, 2009

Dear Mr. Berthouin:

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.

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 (OS) 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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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OWANDY

I-MAX Touch 510(k)

# INDICATION FOR USE STATEMENT

Applicant: OWANDY

510(k) Number : K083057

Device Name: I-Max Touch

Indication For Use:

The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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