(87 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description and performance study sections are not available to provide further clues.
No.
The device is intended for diagnosis, not treatment.
Yes
The device's intended use explicitly states "diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device is described as "Orthophos DS / DS Ceph," which are names typically associated with hardware-based dental imaging systems, not software-only devices. The intended use also describes a "dental radiographic examination," which inherently involves hardware to acquire the radiographic images.
Based on the provided information, the Orthophos DS / DS Ceph is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This involves imaging the patient directly, not testing samples taken from the patient.
- Input Imaging Modality: The input is "dental radiographic," which is an in-vivo imaging technique.
- Anatomical Site: The anatomical site is "teeth, jaw, and oral structures," which are parts of the living patient.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Orthophos DS / DS Ceph operates on the patient directly to produce images for diagnosis.
N/A
Intended Use / Indications for Use
The Orthophos DS / DS Ceph is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
90 EHD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HUMAN" visible around the edge. In the center of the seal is a stylized eagle symbol, represented by three curved lines that suggest the shape of wings. The seal appears to be a government or organizational emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1997
Siemens AG c/o Steven A. Clarke, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re:
K972312 Siemens Orthophos DS/DS Ceph Dental System Dated: June 17, 1997 Received: June 20, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Clarke:
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 the indications 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission 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 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 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 (301) 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.
h. Liao Yu
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
Enclosure
1
510(k) Number (if known): __
Device Name:
Indications For Use:
The Orthophos DS / DS Ceph 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 NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Gherid li. Sijmm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number