(35 days)
Not Found
No
The document describes standard cone beam CT technology and image processing software without mentioning AI or ML capabilities.
No
The device is used for diagnostic support by acquiring images of the head and neck, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device acquires images "for use in diagnostic support."
No
The device description explicitly states it is an "x-ray device (cone beam computed tomography)" and mentions hardware components like a "flat panel detector (FPD)" and "micro focus X-ray tube." While it includes software ("Our original software AsahiVision"), it is an integral part of a hardware system for image acquisition.
Based on the provided information, the Alphard Model X178 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The Alphard Model X178 is an imaging device that directly examines the human body using X-rays.
- The intended use and device description clearly state it's an X-ray device for acquiring images of the head and neck. This is an in-vivo diagnostic method, not in-vitro.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the Alphard Model X178 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 OAS, JAK
Device Description
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)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (cone beam computed tomography)
Anatomical Site
head and neck areas, including the ENT and dentomaxillofacial area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, dentists, and x-ray technologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
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: 81-6-6213-5945 Fax: 81-6-6212-3680 Date Prepared: September 7, 2007 Contact: Tomokuni Hasegawa, Senior VP
-
- 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
-
- 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 ..
-
- 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)
-
- 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.
1
| Manu-
facturer | J. Morita Manufacturing.
Corporation. K052587 | Yoshida Dental
K063622 | TAKARA
BELMONT |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | 3D Accu-I-tomo XYZ Slice
View Tomograph | FineCube | Alphard |
| Indication
for use | The 3D Accu-I-tom0 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 three dimensional
images. The device can also be
used for fluoroscopy during
surgery, mostly for ENT and
TMJ applications and mostly
with a contrast medium. The
device is operated and used by
physicians, dentists, and x-ray
technologists. | FineCube 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. | Identical to Yoshida: 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 |
| Specification
comparison | Focal spot:
0.5mm x 0.5mm
Tube voltage: 60 ~ 90kV
Tube current: 1 ~ 10mA
Exposure time:
Under 18sec
Input: 2.0kVA
Power supply:
AC100V, 50/60Hz
Projection mode:
CT, Panoramic
Detector dimension:
109mm x 111mm | Focal spot:
0.2mm×0.2mm
Tube voltage: 90kV
Tube current: 4mA
Exposure time: 19-37
sec
Input: 1.5kVA
Power supply: AC120V
, 60Hz
Projection mode: CT
Detector dimension:
120mm x 120mm
Pixel size:
200μm×200μm
Image matrix size:
608 x 616 pixels | Focal spot:
0.6mm×0.6mm
Tube voltage 60-100 kV
Tube current: 2-15 mA
Exposure time: 17 sec
maximum
Input: 3 kVA
Power supply: AC 220
v, 50/60 Hz.
Projection mode: CT,
Panoramic
Detector dimension:
Two sizes available:
Varian 2520: 250mm x
200mm Pixel size
127µm x 127µm
1536 x 1920 pixels
Varian 3030, 300mm x
300mm, Pixel size
194µm x 194µm
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that resemble a stylized human figure. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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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