3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17

K073695 · J. Morita USA, Inc. · JAK · Apr 9, 2008 · Radiology

Device Facts

• Record ID: K073695
• Device Name: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
• Applicant: J. Morita USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals. Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

Device Story

Device is a cone-beam X-ray CT system for head and neck imaging. It acquires 360-degree rotational X-ray sequences using a flat panel detector (FPD). Data is stored in a 3D matrix, reconstructed via PC-based image processing, and displayed as 2D and 3D images. Operated by physicians, dentists, or technologists in clinical settings. Output assists in diagnosis of temporal, nasal, orbital, maxillary, mandibular, cervical, and cranial areas. Benefits include high-fidelity, high-resolution visualization of anatomical structures for diagnostic support.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison and performance specifications meeting international standards.

Technological Characteristics

Cone-beam X-ray CT system. Components: rotating arm, main body, base, PC, and software. FPD receptors (Hamamatsu or Varian). Linear-shaped C-arm. Connectivity: PC-based reconstruction and display. Sterilization: Not applicable (non-invasive imaging).

Indications for Use

Indicated for head and neck, ENT, and dento-maxillofacial X-ray imaging for diagnostic support. Used by physicians, dentists, and X-ray technologists. No specific age or gender contraindications listed.

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-I-tomo XYZ Slice View Tomograph MCT-1EXF (K052587)

Submission Summary (Full Text)

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K073645

APR - 9 2008

:

## 510(k) SUMMARY J. Morita USA Inc.'s 3D Accu-I-tomo XYZ Slice view Tomograph Model : MCT-1EX-1F8/F17

## 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 |
| Telephone: [phone] | [phone] |
| Facsimile: 949-581-9688 | [phone] |

#### 2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1 100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

#### 3. Date summary prepared: January 24, 2008

whose details are shown in Table-A below.

···

-

- 4. Device Name:
Trade or Proprietary Name: 3D Accu-I-tomo XYZ Slice view tomograph Model: MCT-1EX-1F8/F17 Note: The name is abbreviated to MCT-1EX-1F8/F17 in the 510(k) submission , and includes two kinds of actual models, MCT-1EX-1F8 and MCT-1EX-1F17

| Common Name: | Cone beam x-ray CT |
|----------------------|-----------------------------------------------------|
| Classification Name: | Computed tomography x-ray system<br>(21CFR892.1750) |
| Product Code: | JAK |

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| Division | Actual model number | Main differences | | |
|--------------------|---------------------|----------------------------------------------------|----------------------|-----------------------------|
| | | Size of<br>radiographic<br>area size<br>D x H (mm) | FPD used | Rotation<br>arm |
| This<br>submission | MCT-1EX-1F8 | 40x40<br>60x60<br>80x80 | Made by<br>Hamamatsu | Linear-<br>shaped-<br>C-arm |
| | MCT-1 EX-1F17 | Note-1 | Made by<br>Varian | |
| The<br>predicate | MCT-1EXF | 40x40<br>60x60 | Made by<br>Hamamatsu | Round-shaped<br>C-arm |

| The MCT-1EX-1F8/F17 includes the actual model numbers specified with the main | |
|-------------------------------------------------------------------------------|--|
| differences as shown in Table-A below. | |

Note-1: Selectable between 170 x 120mm and 40 x 40mm. (Diameter x Height)

Table-A Actual model numbers in MCT-1EX-1F8/F17

## 5. Substantial Equivalency is claimed against the following devices:

3D Accu-I-tomo XYZ Slice View Tomograph MCT-1EXF (K052587)

#### 6. Description of the device:

The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of the head and neck areas, mainly for dentistry. The imaging data are once stored at three dimensional matrix of the examined volume, and are reconstructed by image processing through the Personal Computer, then finally displayed as both two and three dimensional images on the monitor.

It consists of rotation arm part, main body part, base part and accessories including personal computer and software.

This MCT-1EX-1F8/F17 is a slightly modified device from the MCT-1EXF ( K#052587) of J.MORITA MFG. CORP replacing the solid state x-ray imaging device of "Flat Panel Detector (FPD)" with some other additional modifications.

As the main hardware and software are used common, this new MCT-IEX-1F8/F17reserves the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device MCT-1EXF. It is selfexplanatory that the MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF.

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#### 7. Intended Use

#### Intended use

MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

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

### SUBSTANTIAL EQUIVALENCE

The MCT-1EX-1F8/F17 covered by this submission is developed from our legally marketed device, MCT-1EXF (K#052587), modified slightly by replacing FPD to enlarge the radiographic area by using larger field of FPD, without any significant changes for the other components or performances. The comparison including the differences are described at the Table-1 titled " Comparison chart: MCT-1EX-1F8/F17 to MCT-1EXF" at Attachment 5 of this submission.

As is shown in the following comparison summary chart and table , MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF because they have similar general intended uses, technological characteristics and operating principles. As described above, any differences in the technological characteristics do not raise any new issues of safety or effectiveness.

| | This new submission | Predicate device | Difference |
|----------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------|
| Name of<br>model | MCT-1EX-1F8/F17 | MCT-1EXF | Different |
| Manufacturer | J.MORITA<br>MFG. CORP. | J.MORITA<br>MFG. CORP. | Identical |
| Construction | 1)Slightly modified<br>Rotating arm<br>2) The same conventional<br>base/chair/support tower | 1)Conventional<br>Rotating arm<br>2)Conventional<br>base/chair/support tower | Similar |
| Image<br>Receptor | Flat panel detecter | Flat panel detecter | Same |
| Performance<br>spec. | International standards | International standards | Similar |
| Mechanical | Morita made mechanism | Morita made mechanism | Similar |
| Electrical | Morita made electric circuit | Morita made electric circuit | Similar |
| Software | Morita made software | Morita made software | Slightly<br>Different |
| Testing | Mainly done by VDE | Mainly done by VDE | Same |

## Table-1 Comparison summary chart

40

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# Table-2 Comparison summary table

FDA file reference number

Attachment inside notification submission file 510k FDA website print out.

| TECHNOLOGICAL CHARACTERISTICS | Comparison result | |
|--------------------------------------------------|-------------------|--------|
| Model name of Predicate Device | MCT-1EXF | |
| 510(k) number of Predicate Device | K052587 | |
| Indication for use | Identical | |
| Target population | Similar | |
| Design | Slightly changed | Note-1 |
| Materials | Slightly changed | Note-2 |
| Performance | Slightly changed | Note-3 |
| Sterility | Similar | |
| Biocompatibility | Similar | |
| Mechanical safety | Similar | |
| Chemical safety | Similar | |
| 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 | Identical | |
| Thermal safety | Identical | |
| Radiation safety | Identical | |

Note- l

This new devices are designed to enlarge the sizes of radiographic areas, so that some modifications are done over the arm assembly, FPD and software or else Note-2

The new larger size FPD is introduced.

Note-3

The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MAY 20 2010

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

Re: K073695

Trade/Device Name: 3D Accu-I-tomo Slice View Tomograph, Model MCT-1EX-1F8/F17 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 24, 2008 Received: March 25, 2008

Dear Mr. Barritt:

This letter corrects our substantially equivalent letter of April 9, 2008.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or mry vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(K) Number : unknown

Device Name: 3D Accu-I-tomo XYZ Slice view tomograph, Model: MCT-1EX-1F8/F17

Indications for Use:

The Model MCT-1EX-1F8/F17 is a x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento maxillofacial 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 twor and threedimensional images.

The device is operated and used by physicians, dentists and x ray technologists.

Prescription Use

(Par2! CFR801 Subpert D)

AND/OR

Over-The-Counter Use (Part21 CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE)

#### (Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(K) Number :

Prescription Use (Part21CFR801.109)

or

Over-The-Counter Use (Optional Format 1-2-96)

hozi K. Wtz

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices No73695 510(k) Number