(29 days)
None
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML image analysis or processing. The description focuses solely on the device's function as an X-ray generator for image acquisition.
No.
The device is used for diagnosis (generating radiographic images for examination and diagnosis of diseases), not for treating or curing diseases.
Yes
The device is described as being "intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures," which indicates a diagnostic purpose.
No
The device is described as a "dental panoramic X-ray system," which inherently includes hardware components for generating X-ray images. The description focuses on the system's function as a generator of radiographic images, not solely on software for processing or analyzing 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: The Bel-Cypher N dental panoramic X-ray system is a medical imaging device that generates radiographic images of the dento-maxilofacial region. It works by using X-rays to create images of the internal structures of the body.
- No sample analysis: This device does not analyze samples taken from the body. It directly images the patient's anatomy.
Therefore, based on the provided information, the Bel-Cypher N dental panoramic X-ray system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Bel-Cypher N dental panoramic X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
MUH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxilofacial region, teeth, jaw, and oral structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
510(k) SUMMARY
Schiff & Company, located in West Caldwell, NJ and on behalf of Takara Belmont, USA, Inc., is submitting this Special 510(k) Premarket Notification for Bel-Cypher N. The Bel-Cypher N dental panoramic X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Device Details:
| Device Class: | CFR 872.1800 identifies the device as an
Extraoral source x-ray system, Class II |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade or Proprietary Name: | Bel-Cypher N |
| Common or Usual Name: | System, X-ray, Extraoral source, digital |
| Classification Name: | Extraoral source x-ray system |
| Performance Standards: | IEC 60601-1 (1995), IEC 60601-1-1 (2000),
IEC 60601-1-2 (2004), IEC 60601-1-3 (1994),
IEC 60601-1-4 (1999), IEC 60601-2-7 (1998),
IEC60601-2-28 (1993), IEC60601-2-32 (1994) |
Labeling:
Copies are included with this submission.
Establishment Details:
Establishment Registration No: 96114485
Takara Belmont USA, Inc. Belmont Equipment Division 101 Belmont Drive Somerset, NJ 08873-1204
Performance Compliance:
IEC 60601-1 (1995), IEC 60601-1-1 (2000), IEC 60601-1-2 (2004), IEC 60601-1-3 (1994), IEC 60601-1-4 (1999), IEC 60601-2-7 (1998), IEC60601-2-28 (1993), IEC60601-2-32 (1994)
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Substantially Equivalent:
.
.
.
The Bel-Cypher is substantially equivalent to:
| DEVICE NAME | 510(k) NUMBER | MANUFACTURER |
|---|---|---|
| Bel-Cypher | 090020 | Takara Belmont |
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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 Belmont Corporation % Mr. Kunihiko Sobue Product Manager Takara Belmont USA, Inc. 101 Belmont DR SOMERSET NJ 08873
Re: K110160
Trade/Device Name: Bel-Cypher N Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 18, 2011 Received: January 19, 2011
FFB 17 201
Dear Mr. Sobue;
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
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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 (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 S Postel
Mary Pastel, ScD. 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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Indication for Use
510(k) Number (if known):
Device Name: Bel-Cypher N
Indication for Use:
The Bel-Cypher N dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offic of Device Evaluation (ODE)
hul D'Okn
(Division Sign-Off) Division of Radiological Device Office of In Vitro Diagnostic Device Evaluat
510K. K110160
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