ALPHARD CONE BEAM CT, MODEL X178

K072574 · Takara Belmont Corp. · JAK · Oct 18, 2007 · Radiology

Device Facts

• Record ID: K072574
• Device Name: ALPHARD CONE BEAM CT, MODEL X178
• Applicant: Takara Belmont Corp.
• Product Code: JAK · Radiology
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Alphard Model X178 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Story

Alphard Model X178 is a cone beam computed tomography (CBCT) system; utilizes micro-focus X-ray tube and high-resolution flat panel detector (FPD) to acquire 360-degree rotational sequences of head/neck/dentomaxillofacial regions. System offers multiple imaging modes (Dental, Implant, Panoramic, Cephalo) with varying fields of view. Operated by physicians, dentists, or X-ray technologists in clinical settings. AsahiVision software processes raw projection data to reconstruct 3D volumes and multi-planar reformatted (MPR) images. Clinicians view these images to support diagnostic decision-making. Benefits include high-resolution visualization of soft and hard tissues for treatment planning.

Clinical Evidence

Bench, laboratory, and clinical testing performed. No specific quantitative clinical metrics (e.g., sensitivity, specificity) provided in the summary; conclusion of substantial equivalence based on comparative performance testing against predicate devices.

Technological Characteristics

Cone beam CT; micro-focus X-ray tube; 14-bit dynamic range flat panel detector (FPD). Two detector sizes: 250mm x 200mm (127µm pixel) and 300mm x 300mm (194µm pixel). Tube voltage 60-100 kV; tube current 2-15 mA. Connectivity: AsahiVision software for 3D/MPR image display. Power: AC 220V, 50/60 Hz.

Indications for Use

Indicated for diagnostic support via 360-degree rotational X-ray imaging of head, neck, ENT, and dentomaxillofacial areas. Intended for use by physicians, dentists, and X-ray technologists.

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-tomo XYZ Slice View Tomograph (K052587)
• Fine Cube (K063622)

Submission Summary (Full Text)

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KD72574

## 510(k) Summary 510(k) Number

OCT 1 8 2007

### TAKARA BELMONT CORPORATION 1-1-2 CHOME, HIGASHI-SHINSAIBASHI, CHUO-KU Osaka 542 Japan Tel: [phone] Fax: [phone] Date Prepared: September 7, 2007 Contact: Tomokuni Hasegawa, Senior VP

- 1. Identification of the Device: Proprietary-Trade Name: Alphard Model X178 Dental Cone Beam CT Classification Name: Computed Tomography X-Ray System Product Code 90 OAS Common/Usual Name: Dental CT
- 2. Equivalent legally marketed device: K052587 3D Accu-tomo XYZ Slice View Tomograph, manufactured by MORITA and K063622 Fine Cube, manufactured by YOSHIDA
- 3. Indications for Use (intended use) Alphard is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists ..
- 4. Description of the Device: Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.

Imaging mode and range

Alphard VEGA in Alphard series (Alphard-3030)

- . D mode (Dental CT mode: imaging area 51 mm in dia. X Height 51 mm)
- t I mode (Implant CT mode: imaging area 102 mm in dia. X Height 102 mm)
- . P mode (Panoramic CT mode: imaging area 154 mm in dia. X Height 154 mm)

C mode (Cephalo CT mode: imaging area 200 mm in dia. X Height 179 mm) . Alphard VEGA in Alphard series (Alphard-2520)

-
- D mode (Dental CT mode: imaging area 51 mm in dia. X Height 51 mm) .
- . I mode (Implant CT mode: imaging area 102 mm in dia. X Height 102 mm)
- . P mode (Panoramic CT mode: imaging area 169 mm in dia. X Height 119 mm)
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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| Manu-<br>facturer | J. Morita Manufacturing.<br>Corporation. K052587 | Yoshida Dental<br>K063622 | TAKARA<br>BELMONT |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name | 3D Accu-I-tomo XYZ Slice<br>View Tomograph | FineCube | Alphard |
| Indication<br>for use | The 3D Accu-I-tom0 is an x-ray<br>imaging device that acquires a<br>360 degree<br>rotational sequence of the head<br>and neck areas, including the<br>ENT and dentomaxillofacial<br>areas, for use in diagnostic<br>support. The device<br>accomplishes this<br>task by reconstructing a three-<br>dimensional matrix of the<br>examined volume and producing<br>two-dimensional views of this<br>volume, displaying both two-<br>and three dimensional<br>images. The device can also be<br>used for fluoroscopy during<br>surgery, mostly for ENT and<br>TMJ applications and mostly<br>with a contrast medium. The<br>device is operated and used by<br>physicians, dentists, and x-ray<br>technologists. | FineCube is an x-ray<br>device (cone beam<br>computed tomography)<br>that acquires a single<br>360 degree rotational<br>sequence of the head<br>and neck areas,<br>including the ENT and<br>dentomaxillofacial area<br>for use in diagnostic<br>support.<br>The device is operated<br>and used by physicians,<br>dentists, and x-ray<br>technologists. | Identical to Yoshida: an<br>x-ray device (cone beam<br>computed tomography)<br>that acquires a single<br>360 degree rotational<br>sequence of the head<br>and neck areas,<br>including the ENT and<br>dentomaxillofacial area<br>for use in diagnostic<br>support.<br>The device is operated<br>and used by physicians,<br>dentists, and x-ray<br>technologists |
| Specification<br>comparison | Focal spot:<br>0.5mm x 0.5mm<br>Tube voltage: 60 ~ 90kV<br>Tube current: 1 ~ 10mA<br>Exposure time:<br>Under 18sec<br>Input: 2.0kVA<br>Power supply:<br>AC100V, 50/60Hz<br>Projection mode:<br>CT, Panoramic<br>Detector dimension:<br>109mm x 111mm | Focal spot:<br>0.2mm×0.2mm<br>Tube voltage: 90kV<br>Tube current: 4mA<br>Exposure time: 19-37<br>sec<br>Input: 1.5kVA<br>Power supply: AC120V<br>, 60Hz<br>Projection mode: CT<br>Detector dimension:<br>120mm x 120mm<br>Pixel size:<br>200μm×200μm<br>Image matrix size:<br>608 x 616 pixels | Focal spot:<br>0.6mm×0.6mm<br>Tube voltage 60-100 kV<br>Tube current: 2-15 mA<br>Exposure time: 17 sec<br>maximum<br>Input: 3 kVA<br>Power supply: AC 220<br>v, 50/60 Hz.<br>Projection mode: CT,<br>Panoramic<br>Detector dimension:<br>Two sizes available:<br>Varian 2520: 250mm x<br>200mm Pixel size<br>127µm x 127µm<br>1536 x 1920 pixels<br>Varian 3030, 300mm x<br>300mm, Pixel size<br>194µm x 194µm<br>1536 x 1536 pixels |

#### Substantial Equivalence Chart 6

#### 7. Conclusion

After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Alphard Model X178 Dental Cone Beam CT System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 8 2007

Takara Belmont Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K072574

Trade/Device Name: Alphard Model X178 Dental Cone Beam CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 12, 2007 Received: September 13, 2007

### Dear Mr. Kamm:

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 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

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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# Indications for Use

510(k) Number (if known):

Device Name: Alphard Model X178 Dental Cone Beam CT

Indications For Use:

Alphard Model X178 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

loye Thhay
(Division Sign-Off)

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

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