(151 days)
Intraoral dental x-ray machine, wall mounted system that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Sanko dental intaoral x-ray series 70 model_W1070-P
I apologize, but the provided text from the FDA 510(k) K972921 for the Sanko Dental Intraoral X-Ray Series 70 Model W1070-P does not contain any information regarding acceptance criteria, device performance metrics, or study details as outlined in your request.
The document is a clearance letter stating that the device is substantially equivalent to a pre-amendment device and outlines regulatory compliance information and contact details. It does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test or training sets.
- Details on expert involvement, adjudication methods, or ground truth establishment.
- Any mention of multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 JAN
Warren E. Sachs Official Correspondent c/o Lefcoe, Weinstein, Sachs, & Schiff Ltd. Suite 103 904 Kempsville Road Virginia Beach, Virginia 23464
Re: K972921
Sanko Dental Intraoral X-Ray Series 70 Model W1070-P Dated: September 19, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Sachs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to 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). You may, therefore, 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 prokibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 requation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (30) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html":
Sincerely yours.
Wiliau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{1}------------------------------------------------
INDICATIONS FOR USE CERTIFICATE
510 (k) number K
Sanko dental intaoral x-ray series 70 model_W1070-P Device name:
Intraoral dental x-ray machine, wall mounted system that produces x-rays Indications for use: and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
(Please do not write below this line- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _____________
David le. Severson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT. and Radiological Devices 292 510(k) Number
Page 5
Image /page/1/Picture/12 description: The image shows a solid black circle against a white background. The circle is not perfectly round, with some slight irregularities in its shape. The black color is uniform throughout the circle, and the white background provides a stark contrast.
§ 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.