(67 days)
No
The summary does not mention AI, ML, or any related concepts like image processing that would typically indicate the use of such technologies in this type of device.
No.
The device is used to generate images for diagnosis, not for treating a disease or condition.
Yes
The device is described as being "intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures," which indicates a diagnostic purpose.
No
The device description explicitly states it is an "X-ray system," which is a hardware device that generates radiographic images. It is not described as software that processes images or provides analysis.
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 intended use and device description clearly state that the Bel-Cypher system is an X-ray system used to generate images of the dento-maxilofacial region within the patient's body. It does not involve analyzing samples like blood, urine, or tissue.
- The device's function is image generation for diagnosis. It produces radiographic images for visual examination by a dental professional. This is distinct from the analytical processes performed by IVD devices on biological samples.
Therefore, the Bel-Cypher dental panoramic and cephalometric X-ray system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bel-Cypher dental panoramic and cephalometric 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
The Bel-Cypher dental panoramic and cephalometric 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.
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)
ANA-BEL K040748
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only
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
SUMMARY
MAR 1 3 2009
Schiff & Company, located in West Caldwell, NJ and on behalf of Takara Belmont, USA, Inc., is submitting this 510(k) Premarket Notification for Bel-Cypher. The Bel-Cypher dental panoramic and cephalometric 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 |
| Common or Usual Name: | System, X-ray, Extraoral source, digital |
| Classification Name: | Extraoral source x-ray system |
| Performance Standards: | IEC 60601-1-4 (Form D-019-1), IEC 60601-1-4
(1996), ISO 14971 (2007), IEC 60601-1-4
(Form D-018) |
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 60601-1-4 (Form D-019-1), iEC 60601-1-4 (1996), ISO 14971 (2007), IEC60601-1-4 (Form D-018)
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Substantially Equivalent:
The Bel-Cypher is substantially equivalent to:
| DEVICE NAME | 510(K) Number
STATE LA PARTY & STANLAN | STATISTICS OF THE OFFICE OF CONSULTION OF CHEARTH OF CHEARTH OF CHEARTH AND THE OFFICE OF CHEARTH AND THE OFFICE OF CHEARTH AND THE FORM OF CHEARTH AND THE OFFICE AND THE OF
MANUFACTURER |
|-------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANA-BEL | 040748 | Takara Belmont |
Comparison of the Bel-Cypher to the ANA-BEL and Generic X-Ray Film/Screen appears in Attachment 3 of this submission.
Installation, operating instructions, care and maintenance are also included with this submission.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2009
TAKARA Belmont Corporation % Mr. Kunihiko Sobue Product Manager TAKARA Belmont USA, Inc. 101 Belmont Drive SOMERSET NJ 08873-1204
Re: K090020
Trade/Device Name: Bel-Cypher Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 2, 2009 Received: January 5, 2009
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. Drue, 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 os 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 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 892.xxx | (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 Biometrics' (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. Youmay obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.
Sincerely yours,
Laura B. Morris
anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known):
Device Name: Bel-Cypher
Indicaiton for Use:
The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region for use a generator of rainomination and diagnosis of diseases of the teeth, iaw, 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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
IND