(58 days)
Not Found
Not Found
No
The summary describes a traditional imaging device and lacks any mention of AI, ML, or related concepts.
No
The device is described as producing diagnostic images, which means it is used for diagnosis, not therapy.
Yes
The device is described as producing "diagnostic images," indicating its role in the diagnostic process.
No
The device description is not found, but the intended use clearly describes a device that produces diagnostic images using a "linear tomographic method," which implies hardware for image acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes producing diagnostic images of anatomical structures (dental arch, skull, dentition, TM-joints) using a linear tomographic method. This is a form of medical imaging, not a test performed on biological samples in vitro (outside the body).
- Device Description: While not found, the intended use clearly points to an imaging device.
- Mentions image processing, AI, DNN, or ML: The absence of these terms, while not definitive, further supports the idea that this is a standard imaging device rather than a complex analytical system often associated with IVDs.
- Input Imaging Modality: "linear tomographic method" is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The listed anatomical sites are parts of the human body being imaged, not biological samples being tested.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to create images of the body itself.
N/A
Intended Use / Indications for Use
Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the whole face, of the skull and lateral images of dental arch using linear tomographic method.
Product codes
90 EHD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
linear tomographic method
Anatomical Site
whole face, skull, dental arch, dentition, TM-joints
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
Not Found
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 1997
RISTO Mynttinen Regulatory Affairs Intstrumentarium Corporation Imaging Division P.O. Box 20 FIN-04301 Tuusula, Finland
Re:
K973642 Orthopantomograph® OP100 and Orthoceph® OC100 Dated: September 18, 1997 Received: September 24, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Mynttinen:
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 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 (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 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 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,
William Yim
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
Image /page/1/Picture/0 description: The image contains the words INSTRUMENTARIUM and imaging. The word INSTRUMENTARIUM is in a smaller font and is above the word imaging. To the left of the words is a black graphic that looks like a stylized letter N.
October 28, 1997
K973642 5 10(k) Number:
l Devic : Name:
ﻢ. ﻭﻣ
Orthopantomograph® OP100 and Orthoceph® OC100
ndic: tions For Use: Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be Onlopantomograph - Of 100 and Chination, Then interest of dentition, TM-joints used for producing diagnostion it af race of the of the surfall and lateral images of dental arch using linear tomographic method. _______
Instrumentarium Corp. Imaging Division
Risto Mynttinen
Regulatory Affairs
(Division Sign-Off)
( = colon of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devices,
510(k) Number K973642
ﮨﮯ Prescription Use. "er 21 CFR 801.109)