3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF

K052587 · J. Morita USA, Inc. · JAK · Dec 27, 2005 · Radiology

Device Facts

• Record ID: K052587
• Device Name: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
• Applicant: J. Morita USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The MCT-1 EX F is intended to be used for three dimensional X-ray Computed The ITCT + DF + 1 to med and neck by limited cone shaped x-ray beam projected on to an FPD to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

Device Story

MCT-1 EX F is a limited cone beam X-ray CT scanner for head and neck imaging. Device uses rotating arm and base to acquire 360-degree rotational X-ray sequences; replaces previous image intensifier (XII) with Flat Panel Detector (FPD). System reconstructs 3D matrix of examined volume; produces 2D and 3D images for diagnostic support. Operated by physicians, dentists, and technologists in clinical settings. High-resolution images obtained in short duration; compact system design; low radiation dosage. Healthcare providers use displayed images to assess complex hard tissue morphology; aids clinical decision-making for diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Device certified for CE marking by VDE; performance specifications compared to predicate via technical analysis.

Technological Characteristics

Limited cone beam X-ray CT; Flat Panel Detector (FPD) image receptor; rotating arm and base mechanical structure; MCT electric circuit; compact form factor. Software is identical to predicate. Standards met include VDE certification.

Indications for Use

Indicated for diagnostic support in head and neck areas, including ENT and dentomaxillofacial regions. Used by physicians, dentists, and x-ray technologists to acquire 360-degree rotational X-ray sequences, reconstruct 3D volumes, and display 2D/3D images.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• 3D Accu-1-tomo XYZ Slice View Tomograph MCT-1 EX (K030450)

Submission Summary (Full Text)

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## DEC 2 7 2005

## 510(k) SUMMARY

J. Morita USA. Inc.'s

3D Accu-I-tomo XYZ Slice View Tomograph MCT-1 EX F

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

Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: [phone] Facsimile:

### 2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

- August 31, 2005 3. Date summary prepared:
- Device Name: 4. 3D Accu-I-tomo XYZ Slice View Tomograph Trade or Proprietary Name: MCT-1 EX F Model:

Cone beam x-ray CT Common Name: Computed tomography x-ray system Classification Name: ( 21CFR 892.1750 )

901AK Product Code :

- 5. Substantial Equivalency is claimed against the following device: 3D Accu-1-tomo XYZ Slice View Tomograph MCT-1 EX From 510k # K030450 J. MORITA MFG.CORP

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#### 6. Description of the device:

The MCT-1 EX F is an X-ray CT using the limited cone beam. MCT-1 EX F makes diagnosis be possible due to its high resolution three dimensional images for small diagnosis be possible add to the extremely complex morphology of the hard tissue of the head and neck region

High resolution images are obtained in the same short period as that of the Panoramic Radiology. Low X-ray radiation dosage is realized and the overall system structure is assembled to be compact unit.

The J.MORITA. MFG. CORP. has manufactured the MCT-1EX as the original model of such kind of X-ray scanner, and modify the device for MCT-1 EX F by replacing the image receptor , XII for FPD ( Flat Panel Detector).

### 7. Intended Use

The MCT-1 EX F is intended to be used for three dimensional X-ray Computed The ITCT + DF + 1 to med and neck by limited cone shaped x-ray beam projected on to an FPD to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

#### Safety and effectiveness of the device 8.

As the MCT-1 EX F is modified from our legally marketed device, MCT- 1 EX (K#030450) by replacing image receptor from XII to FPD with remaining all the other parts be common, so that the MCT-1 EX F is substantially equivalent to MCT-1EX as is shown in the comparison summary table below because they have . . similar general intended uses, technological characteristics and operating principles.

Any differences in the technological characteristics do not raise any new issues of safety or effectiveness.

| | This new submission | Predicate | Difference |
|-------------------|-----------------------|-------------------------|------------|
| Name of the model | MCT-1 EX F | MCT-1EX | Different |
| Manufacturer | J.MORITA MFG. CORP. | J.MORITA MFG. CORP. | Identical |
| Construction | Rotating arm and base | Rotating arm and base | Same |
| Image Receptor | Flat Panel Detector | X-ray image intensifier | Different |
| Chin Rest | Equipped | Equipped NOTE-1 | Identical |
| Performance spec. | Computed tomography | Computed tomography | Identical |
| Mechanical | MCT mechanism | MCT mechanism | Same |
| Electrical | MCT electric circuit | MCT electric circuit | Same |
| Software | MCT software | MCT software | Identical |
| Testing | VDE NOTE-2 | VDE NOTE-2 | Same |

NOTE-I The original submission does not include Chin rest , but this is noluded in MCT-1EX through our in-house revision procedure named "510(K) memo " documentation as shown at Attachment 11 in this submission

NOTE-2 The notified body of VDE has tested and certified for CE marking with CB report on MCT-1 EX F which is to be accessed

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| MCT-1 EX F to MCT-1EX | |
|-----------------------------------------------------|-----------------------------------|
| FDA file reference number | 510k number of MCT-1EX<br>K030450 |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |

Substantial Equivalent comparison summary table

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Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, with three horizontal lines above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

J. Morita USA. Inc. c/o Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 11" Floor WASHINGTON DC 200005

Re: K052587

Trade/Device Name: 3D Accu-I-tomo XYZ Slice View Tomograph Model MCT-1 EXF Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 19, 2005 Received: October 11, 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 (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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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 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. Hodgdon

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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K052587

510(k) Number (if known):

3D Accu-I-tomo XYZ Slice View Tomograph Model MCT-1 EXF Device Name:

Indications For Use:

The Model MCT-1 EXF is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and threedimensional images. The device is operated and used by physicians, dentists, and x-ray technologists.

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)

Daniel R. Heymann

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

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