(448 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No.
The device is described as an "x-ray device (cone beam computed tomography)" for "diagnostic support" and "acquires a single 360 degree rotational sequence...for use in diagnostic support," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "for use in diagnostic support," and the "Device Description" section refers to it as an "X-ray CT diagnostic device."
No
The device description explicitly states it is an "arm type X-ray CT diagnostic device," indicating it is a hardware device that acquires images.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is an x-ray imaging system. It uses radiation to create images of the internal structures of the head and neck. It does not analyze biological samples.
- Intended Use: The intended use is for "diagnostic support" through imaging, not through the analysis of biological specimens.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bel-Cat 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. (Not for mammographic use.)
This 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. Not for mammographic use.
Product codes
90 OAS
Device Description
The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.
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
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 test data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Bel-Cat Dental Cone Beam CT System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 19 2011
510(k) Summary 510(k) Number K10 1 / 8 / 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: April 19, 2010 Tomokuni Hasegawa, Senior VP Contact:
-
- Identification of the Device: Proprietary-Trade Name: Bel-Cat Dental Cone Beam CT Classification Name: Computed Tomography X-Ray System Product Code 90 OAS Common/Usual Name: Dental CT
- Equivalent legally marketed device: TAKARA BELMONT Alphard K072574 2.
-
- Indications for Use (intended use) Bel-Cat 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. (Not for mammographic use.)
-
- Description of the Device: The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.
| Model | Bel-Ca: | Bel-Ca: PA | Bel-Ca1 CM |
|---|---|---|---|
| Exposure modes | |||
| CCD | |||
| Panoramic | |||
| CCD | |||
| Cephalometric | |||
| FPD | |||
| Panoramic | |||
| CT |
- Safety and Effectiveness, comparison to predicate device. The results of bench, test 5. laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
| Model | TAKARA BELMONT Alphard
K072574 | TAKARA BELMONT Bel-Cat |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for use | 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. | SAME |
| Specification
comparison | 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 | Focal spot: 0.5mm×0.5mm
Tube voltage 60-95 kV
Tube current: 2-12 mA
Exposure time: 17 sec maximum
Input: 2 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 1313, 130mm x130mm, Pixel
size
127µm x 127µm
1024 x 1024 pixels |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing both bench test data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Bel-Cat Dental Cone Beam CT System is as safe and effective as the predicate device, 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
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
Takara Blemont Corp. % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
JUL 19 2011
Re: K101181
Trade/Device Name: Bel-Cat (various models) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 25, 2011 Received: May 27, 2011
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 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 comply with 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
3
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K10 // 81
Device Name: Bel-Cat (various models)
Indications For Use:
This 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. Not for mammographic use.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
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 Radiologica Office of In Vitro Diagnostic Device Evaluati
510K
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