(70 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is for a standard extraoral x-ray system.
No
The device is described as an x-ray system for diagnosis, not for treating diseases or conditions.
Yes
The device is described as being intended for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures," which indicates a diagnostic function.
No
The device description explicitly states it is an "extraoral x-ray system," which is a hardware device.
Based on the provided information, 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 Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system. It uses radiation to create images of the teeth, jaw, and oral structures. This is an in vivo diagnostic method (performed on a living organism), not an in vitro method.
- 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 analyzing samples from the patient.
Therefore, the description clearly indicates a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.
Product codes
90 MUH, 76 EAG
Device Description
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
teeth, jaw, and 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing people or services.
APR 3 0 1999
Sirona Dental Systems, GMBH C/O Sheila Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants 49 Plain Street North Attleboro, Massachusetts 02760-4153
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RE: K990528 Orthophus 3/3 Ceph/3 DS Dated: April 28, 1999 Received: April 28, 1999 Regulatory Class: II 21 CFR 872.1800 and 872.1830 Procode: 90 MUH and 76 EAG
Dear Ms. Hemeon-Heyer:
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 redassified 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 II (Special Controls) or dass 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 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.
ff 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT 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
1
510(k) Number (if known): K990528
Device Name: Orthophos 3/3 Ceph/3 DS
Indications For Use:
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Sirona Dental Systems 510(k) Orthophos 3/3 Ceph/3 DS
February 18, 1999