(65 days)
Not Found
No
The summary describes standard cone beam CT technology and image reconstruction, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an x-ray imaging device for diagnostic support, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "use in diagnostic support."
No
The device description explicitly states that the FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system is a hardware component responsible for creating and acquiring the x-ray images. Therefore, the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the FineCube clearly states it is an x-ray device that acquires images of the head and neck areas of a patient. It is an imaging device that works directly on the patient, not on a biological sample.
- The intended use is for diagnostic support based on imaging. The device acquires images for diagnostic support, which is a function of medical imaging devices, not IVDs.
The description aligns with a medical imaging device used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray device (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.
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
8 2007
FEB
510(k) Summary 510(k) Number
The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi, Sumida-Ku Tokyo, JAPAN 130 85164 Tel: 81-3-3631-2165 Fax: 81-3-3633-9427 www.yoshida-net.co.jp Date Prepared: November 30, 2006 R&D Department (テクニカルセンタ) Contact: Hidenori Watanabe(渡辺英憲)
- l . Identification of the Device: Proprietary-Trade Name: FineCube Classification Name: Computed Tomography X-Ray System Product Code 90 JAK Common/Usual Name: Dental CT
-
- Indications for Use (intended use) 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..
-
- Description of the Device: The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
-
- 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.
| Manufacturer | Imaging Sciences
International Inc.
K051980 | J. Morita
Manufacturing.
Corporation.
K030450 | Yoshida Dental |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | DVT SCANNER | 3D Accu-l-tomo XYZ
Slice View Tomograph | FineCube |
| Manufacturer | Imaging Sciences | J. Morita | Yoshida Dental |
| | International Inc. | Manufacturing. | |
| | K051980 | Corporation. | |
| | | K030450 | |
| Indication for use | The DVT Scanner
constructs
a three dimensional model
from images taken during a
rotational X-ray sequence.
The DVT Scanner is
intended to be used
whenever a dentist, oral
surgeon, or other physician
needs 3D information of
high contrast objects. The
DVT Scanner is optimized
for imaging of TM Joint
studies, mandible &
maxilla for implant
planning, sinuses, the
maxillofacial complex,
temporal bone, etc. | The 3D Accu-1-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. |
| Specification
comparison | Focal spot: 0.6mm
Tube voltage:
60,80,100,120kV
Tube current: 10,15mA
Exposure time: 9.6sec
Emergency stop method:
Emergency stop switch
Input: 10kVA
Power supply: AC200V
Projection mode: CT
Detector dimension:
9.7 / 4.5 inch | Focal spot:
0.5mm x 0.5mm
Tube voltage: 60 ~ 90kV
Tube current: 1 ~ 10mA
Exposure time:
Under 18sec
Emergency stop method:
Emergency stop switch
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 /
37sec
Emergency stop
method:
Emergency stop switch
Input: 1.5kVA
Power supply: AC120V
, 60Hz
Projection mode: CT
Detector dimension:
120mm x 120mm
Pixel size:
200μm×200μm
Image matrix size:
608 × 616 pixels |
6. Substantial Equivalence Chart
1
7. . Conclusion
After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Yoshida Dental that the FineCube Dental CT System is appare 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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a logo to the left of the text. The logo is a stylized image of a human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
The Yoshida Dental Mfg., Co., Ltd. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
8 2007
Re: K063622
Trade/Device Name: FineCube Dental CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 1, 2006 Received: December 20, 2006
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 (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.
Image /page/2/Picture/9 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a stylized font. The word "Centennial" is below the letters. There are three stars below the word "Centennial."
Protecting and Promoting Public Health
3
Page 2 -
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: regirstration 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 sectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-0150,
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 10(x) marketed predicate device results in a classification for your device and thus, perceits 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
---|---|---|
21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
21 CFR 894.xxx | (Radiology) | 240-276-0120 |
Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
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):
K063/22
Device Name: FineCube Dental CT System
Indications For Use:
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.
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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