VERAVIEW IC 5, MODEL XDP1

K053220 · J. Morita USA, Inc. · MUH · Jan 6, 2006 · Dental

Device Facts

• Record ID: K053220
• Device Name: VERAVIEW IC 5, MODEL XDP1
• Applicant: J. Morita USA, Inc.
• Product Code: MUH · Dental
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Veraview IC 5 (XDP1) is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.

Device Story

Veraview IC 5 (XDP1) is an extraoral dental panoramic X-ray system. Device captures X-ray images of teeth, jaw, oral structures, TM-joints, and skull using a CCD sensor. System features automatic exposure control. Operated by dental professionals in clinical settings. Produces digital panoramic, pedodontic, and TMJ quadruple images. Output used by clinicians for diagnostic assessment of dento-maxillofacial area. Benefits include digital processing of radiographic images for improved diagnostic workflow.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Extraoral dental X-ray system; rotating arm and base construction; CCD sensor image receptor; automatic exposure control; electrical circuit; complies with international performance standards.

Indications for Use

Indicated for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints, and skull in patients requiring extraoral 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

• Veraviewepoes Model VE (K030699)

Submission Summary (Full Text)

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K053220

JAN 6 2006

# 510(k) SUMMARY J. Morita USA Inc.'s Veraview IC 5 XDP1

## 1. Submitter Name and Address with Phone/Fax :

Registration No. 2081055 Registration No. 3002807636 Initial Distributor: Manufacturer: J. Morita USA, Inc. J. MORITA MFG. CORP. 9 Mason 680 Higashihama Minami-cho Irvine, CA 92618 Fushimi-ku, Kyoto USA Japan 612-8533 949-581-9600 Telephone: [phone] Facsimile: 949-581-9688 [phone]

#### 2. Contact Person

- Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]
#### 3. Date summary prepared: October 17, 2005

#### 4. Device Name:

| Trade or Proprietary Name: | Veraview IC 5 Model XDP1 |
|----------------------------|---------------------------------------------------------|
| Common Name: | Dental Panoramic X-ray Unit |
| Classification Name: | Extraoral Source dental X-ray System<br>(21CFR872.1800) |
| Product Code : | MUH |

- 5. Substantial Equivalency is claimed against the following device: Veraviewepoes Model VE from J. MORITA MFG.CORP.
510k # : K030699

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## 6. Description of the device:

The Veraview IC5 Model XDP1( hercinafter XDP1) is an extragral source dental panoramic x-ray system intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure.

The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images.

This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control.

Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).

## 7. Intended Use

The XDPI is used with the purpose to obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc.

### 8. Safety and effectiveness of the device

This Model XDPI is a modified device from the Veraviewepoes Model VE ( K#030699) of J.MORITA MFG. CORP. by climinating the film image receptor to CCD sensor. However, not only the main hardware is used unchanged in the same way as the predicate device, but also the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics, so that the XDP is substantially equivalent to the Veraviewepoes Model VE ( K#030699).

Although there are minor differences in the characteristics between the Model XDP I and the predicate device as is shown at Table-1 and Table-2, these differences do not raise new questions of safety or effectiveness because they are able to be considered as almost same .

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| | This new submission | Predicate | Difference |
|-------------------|-------------------------|---------------------------------|------------|
| Name of the model | XDP1 | X550P-D-UL | Different |
| Manufacturer | J.MORITA MFD. CORP. | J.MORITA MFD. CORP. | Identical |
| Construction | Rotating arm and base | Rotating arm and base | Similar |
| Image Receptor | X-ray CCD sensor | X-ray film and X-ray CCD sensor | Different |
| Performance spec. | International standards | International standards | Similar |
| Mechanical | XDP1 mechanism | X550P mechanism | Similar |
| Electrical | XDP1 electric circuit | X550P electric circuit | Similar |
| Software | XDP1software | X550P software | Different |
| Testing | VDE | VDE | Similar |

Table-1 Comparison summary chart

Table-2 Comparison summary table

#### FDA file reference number 510k number ; K030699

Attachment inside notification submission file 510k FDA website print out

| Model name of Predicate Device | X550P-D-UL |
|--------------------------------------------------|-------------------|
| 510(k) number of Predicate Device | K030699 |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Identical |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Similar |
| Thermal safety | Identical |
| Radiation safety | Identical |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

2006

J. Morita USA, Inc. c/o Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 WASHINGTON DC 20005

Re: K053220 Trade/Device Name: Veraview IC 5(XDP1)

Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: MUH Dated: November 15, 2005 Received: November 17, 2005

Dear Mr. Barritt:

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.

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/13 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized drawing of an eagle or similar bird, depicted with three curved lines representing its body and wings. The text around the border appears to be part of the organization's name, but it is difficult to read due to the image quality and orientation.

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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 (o 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. brigdon

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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## Indications for Use

to known 510(k) Number (if known):

K053220

XDP1 Device Name:

Indications For Use:

The Veraview IC 5 (XDP1) is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.

Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

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

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