EV APAN DIGITAL, MODEL K1VSM2000

K041120 · Afp Imaging Corp. · MUH · Aug 30, 2004 · Dental

Device Facts

• Record ID: K041120
• Device Name: EV APAN DIGITAL, MODEL K1VSM2000
• Applicant: Afp Imaging Corp.
• Product Code: MUH · Dental
• Decision Date: Aug 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.

Device Story

Digital imaging system replacing traditional dental X-ray film; utilizes solid-state sensor to capture radiation as charge pattern; electronic signals digitized and transmitted to computer workstation; used in clinical environments by dental professionals; enables image capture, enhancement, storage, and evaluation; facilitates routine dental radiography; provides high-quality digital dental X-rays; supports clinical decision-making through improved visualization and data management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Solid-state X-ray sensitive imaging array; replaces traditional photographic film; connects via cable to digitizing and control electronics; interfaces with standard computer hardware; intended for use with dental panoramic X-ray systems.

Indications for Use

Indicated for patients requiring dental panoramic radiographic imaging. Used by qualified dental professionals in a clinical setting.

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

• Signet Radiology DXIS (K983283)
• Trophy DigiPan (K961826, K991912, K012514)

Reference Devices

• Villa Strato X (K002432)

Submission Summary (Full Text)

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AUG 3 0 2004

Koyllzo

# 510(k) Premarket Notification Summary For Owandy SA EVApan Digital (also known as model K1VSM2000) Dental Panoramic Sensor

### 1. SPONSOR

AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523

| Contact Person: | James Johnson |
|-----------------|----------------|
| Telephone: | [phone] |

Date Prepared: April 27, 2004

### 2. Device Name

| Proprietary Name: | EVApan Digital / K1VSM2000 panoramic sensor |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Accessory to Extra oral X-Ray System |
| Classification Name: | Extra oral Source X-Ray System Accessory |

## 3. PREDICATE DEVICES

Signet Radiology DXIS

Trophy DigiPan

### 4. Intended Use

The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.

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### 5. Device Description

The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.

## 6. Substantial Equivalence and Technological Characteristics

The EV Apan Digital / K 1 VSM2000 System is substantially equivalent to the several other Digital Panoramic systems currently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K I VSM2000 System and the predicate devices listed, the Trophy DigiPan and the Signet DXIS, have the same intended use. All are intended to be used with a Dental Panoramic X-ray Source, Dental Image Management Application Software and standard computer hardware for the capture, evaluation, and storage of high quality digital dental X-rays using existing X-Ray equipment. The system and its predicates all consist of an X-ray sensitive solid state imaging array installed in the Dental Panoramic X-ray system in place of the traditional photographic film, connected via cable to digitizing and control electronics which in turn interface to a computer via a standard interface. The proposed and predicate devices are intended for patients receiving routine dental radiography, in a clinical environment by dental professionals.

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Image /page/2/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 that resembles three human profiles facing to the right, with wavy lines underneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 3 0 2004

Mr. James Johnson Director of Sustaining Engineering AFP Imaging Corporation 250 Clearbrook Road ELMSFORD NY 10523

Re: K041120

Trade/Device Name: EVApan Digital / K1VSM2000 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 MUH Dated: July 7, 2004 Received: July 9, 2004

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beenemed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrobard, 10 stgm 3
commerce prior to May 28; 1976, the enactment date of the Medical Device Amendments, or to conner oc pror to may 20, 20, 20, 11, 11, 10, 20, 2017, 11, 1998, 1999, 1999, 1999, 1999, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Flor (110) that the device, subject to the general controls provisions of the Act. The I ou may, ate. en ovisions 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 If your device is olassinod (500 as 010) as . Existing major regulations affecting your device can may be subject to satin additions, 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 that I Dri has made a occertires and regulations administered by other Federal agencies. You must comply or any I Gaeral statues and resaincluding, 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 quality of 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 Section 510(k) I his letter will anow you to ocgain nameding your and premarket notification. The FDA miding of basification 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 If you desire specific advice for your development on one of the following numbers, based on the regulation number at the top of the 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 Adultionally, for questions on the prosses note the regulation entitled, "Misbranding Other of Comphanoo at (2017 97) 700 (21CFR Part 807.97) you may obtain. Other general by reletence to premarket notification - (r the Act may be obtained from the Division of Small mormation on your responsional and Consumer Assistance at its toll-free number [phone] or 141111443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

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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## 510(k) Premarket Notification for EVApan Digital / K1VSM2000 Dental Panoramic Sensor System

Page of

510(k) Number (if known): Ko 4 | 20_

EVApan Digital / K1VSM2000 Device Name:

Indications for Use:

The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with The EVApan Digital / K V SW2000 Demail 1 4302439), manufactured by VILLA SISTEMI
the STRATO Panoramic X-ray System (K002432), manufactured by Mation Station station station s the STRATO Panoramic X-Iay System (R002452), Manatoval 2017
MEDICALI S.P.A (registration number 8021091) and a computer work station station for Dental Panoramic Radiographic Imaging.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

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

**Prescription Use**
(Per 21 CFR 801.109)