(74 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related terms, and the device description is not available.
No.
The device is described as producing diagnostic x-ray radiographs, indicating it's used for diagnosis, not treatment.
Yes
The device is intended to be used for "producing diagnostic x-ray radiographs", indicating its role in diagnosis.
No
The device is an x-ray machine, which is a hardware device. The summary describes its function in producing radiographs, which is a hardware-based process.
Based on the provided information, the Orthopantomograph® OP100D is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). They are used in vitro (outside the body).
- The Orthopantomograph® OP100D is an imaging device that produces diagnostic x-ray radiographs of structures within the body (dentition, TM-joints, oral structures). This is an in vivo (within the body) diagnostic method.
Therefore, the intended use and function of this device clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.
Product codes
90 MUH
Device Description
Not Found
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
dentition, TM-joints and other 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)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its head facing left and its wings spread. The eagle is made up of three curved lines, which give it a sense of movement and flight.
SEP 2 8 1999
Mr. Tommi Jokiniemi Regulatory Affairs Engineer Instrumentarium Corp. Imaging Division 300 West Edgerton Avenue Milwaukee, WI 53207
Re: K992385 Orthopantomograph® OP100D Dated: July 9, 1999 Received: July 16, 1999 Product Code: 90 MUH Regulatory Class: Il (two) 21 CFR 872.1800
Dear Mr. Jokiniemi:
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 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, 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 the Electronic Product 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 questions on the promotion 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/cdch/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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510(k) Number (if known): __
Device Name:
Indications For Use:
Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David L. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)