(153 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or other sections. There is no mention of image processing that would typically involve AI/ML algorithms for analysis or enhancement.
No
The device is described as an X-ray unit intended for "examination and diagnosis," not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device description explicitly states it is an "extraoral source X-ray system," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system. It uses X-rays to create images of the teeth, jaw, and oral structures. This is an imaging device that works by sending radiation through the body and capturing the resulting image, not by analyzing samples taken from the body.
The provided information clearly describes a medical imaging device used for diagnosis based on visual examination of X-ray images, not laboratory analysis of biological samples.
N/A
Intended Use / Indications for Use
The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
Product codes
90 EHD
Device Description
The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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 Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lars Moring Regulatory Affairs Manager ... Planmeca Oy·· Asentajankatu 6 FIN-00810 Helsinki, FINLAND Re: K970812
Planmeca Dimax Digital X-ray ... Dated: May 5, 1997 Received: May 7, 1997 Regulatory class: II 21 CFR 897.1800/Procode: 90 EHD
AUG - 5 1997
Dear Mr. Moring:
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 III (Premarket Approval), it may be الانتال 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 market 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
Sincerely yours,
Nliau Yu
Lilian 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
ANMECA
March 3. 1997
Ref.: 510(k) Notification Extraoral source X-ray system Planmeca Dimax Digital Panoramic X-ray
INDICATIONS FOR USE
The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
The use of the device is allowed only under supervision of a dentist.
Luis leal
Lars Moring Regulatory Affairs Manager
Date: March 3, 1997
William Yin
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Ky 510(k) Number __
Prescription Use . (Per 21 CFR 801.109)
Image /page/1/Picture/15 description: The image shows a black and white drawing of what appears to be an eye. The eye is closed, and the eyelashes are visible. The drawing is simple and stylized, with thick black lines used to create the shape of the eye and eyelashes.
s