HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM

K033248 · Hitachi Medical Systems America, Inc. · MUH · Oct 20, 2003 · Dental

Device Facts

• Record ID: K033248
• Device Name: HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: MUH · Dental
• Decision Date: Oct 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Hitachi CB MercuRay system is an x-ray imaging device that uses a cone beam with a 360°rotational sequence, providing two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.

Device Story

CB MercuRay is a cone-beam X-ray system for head/neck imaging. Input: 360-degree rotational X-ray emission; 288 projection views. Processing: offset correction; logarithmic conversion; detector sensitivity/geometric distortion/runover corrections; 3D volume reconstruction (512^3 matrix). Output: 2D images or 3D volume reconstructions. Usage: Clinic setting; operated by trained personnel. Patient position: Upright, seated. Clinical utility: Planning and diagnostic support for ENT and dentomaxillofacial applications. Benefits: Provides 3D visualization of anatomical structures for improved diagnostic accuracy.

Clinical Evidence

Bench testing only. System validated according to applicable standards. Risk and hazard analysis performed to confirm safety and effectiveness compared to predicate.

Technological Characteristics

Cone-beam X-ray system; U-arm gantry; 9" or 12" Image Intensifier; 100M pixel CCD camera. Upright, seated patient positioning. 360-degree rotation. 2D and 3D volume reconstruction capabilities. Four selectable fields of view.

Indications for Use

Indicated for patients requiring head and neck imaging, including ENT and dentomaxillofacial areas, for diagnostic support and treatment planning.

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

• NewTom QR-DVT 9000 (K003787)

Submission Summary (Full Text)

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OCT 2 0 2003

K033248
Page 1 of 2

# HITACHI

#### HITACHI MEDICAL SYSTEMS AMERICA, INC.

1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel.: [phone] Fax: [phone]

# 510(k) Summary

## Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: [phone]<br>fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | August 29, 2003 |

# Device Name

| Device Name: | Extraoral source x-ray system |
|-------------------------|--------------------------------|
| Trade/Proprietary Name: | CB MercuRay |
| Common Name: | Dental X-ray System |
| Classification Name: | Extraoral source x-ray system. |
| Classification Number: | Sec. 872.1800 |

# Predicate Device

Predicate Device: NewTom QR-DVT 9000, 510(k) K003787

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# Device Description

#### Function

The CB MercuRay system is an x-ray device that uses a cone beam with a 360°rotational sequence, providing twodimensional images and three-dimensional volume reconstructions for ENT and dentomaxillofacial applications.

#### Scientific Concepts

The CB MercuRay system incorporates conebeam technology. The x-rays are continuously emitted in a cone shape during rotation providing image data of 288 views. Projection images acquired are applied with offset correction and logarithmic conversion. The data are then applied with corrections for detector sensitivity, geometric distortion and runover of the subject. The acquired data can be presented as 2-dimensional images or can be reconstructed as a 3dimensional 5123 matrix image.

#### Physical and Performance Characteristics

The system consists of two main components; scanner and console. The scanner contains a U-arm with an x-ray generator with a 9" or 12" Image Intensifier and a 100M pixel CCD camera horizontally facing each other. The Uarm rotates horizontally around the patient's head. Data acquisition is performed with the patient in an upright, seated position. Images can be printed or exported on standard computer media.

## Device Intended Use

The CB MercuRay system is an x-ray imaging device that provides two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.

# Device Technological Characteristics

The CB MercuRay system acquires data in the same manner as the predicate device. Physically, the significant difference is that the CB MercuRay positions the patient in an upright, seated position during acquisition. The predicate device acquires data with the patient lying down on a table. The remaining differences are increased options and features with the CB MercuRay such as four different fields of view and increased 3D features within the viewing software.

Despite these small differences, the CB MercuRay system is technologically equivalent in concept, function, and performance to the predicate device.

# Conclusions

The CB MercuRay system has been developed and validated according to applicable standards. Testing has proven that the CB MercuRay system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 2 0 2003

Hitachi Medical Systems America, Inc. % Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K033248

Trade/Device Name: CB MercuRay Dental Cone-Beam X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: October 6, 2003 Received: October 7, 2003

Dear Mr. Sherratt:

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 (PMA). it may be subject to 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 electronic product radiation 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) 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 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 Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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) Number (if known): K033248
Device Name: CB MercuRay Dental Cone-beam X-ray System

Indications for Use:

The Hitachi CB MercuRay system is an x-ray imaging device that uses a cone beam with a 360°rotational sequence, providing two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Boylon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033248

Prescription Use

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Over-the-Counter Use