(60 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the hardware and basic software control for image acquisition, not advanced image analysis or decision-making.
No
The device is described as diagnostic imaging equipment (dental x-ray) for producing images. It is used for diagnosis, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that the device is "software controlled diagnostic panoramic dental x-ray equipment."
No
The device description explicitly states it is "diagnostic panoramic dental x-ray equipment" and describes different hardware configurations (Panoramic and Tomographic unit, Panoramic unit, Panoramic, Tomographic and Cephalometric unit, Panoramic and Cephalometric unit). This indicates it is a hardware device that is software-controlled, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the OS1000 series is x-ray equipment used to produce images of dentition, TMJ, and sinuses. This is an in vivo diagnostic method, meaning it examines the body directly, not specimens taken from the body.
Therefore, while it is a diagnostic device, it falls under the category of medical imaging equipment rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible.
Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit
The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit
Product codes
90 EHD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dentition with multiple orbit, TMJ, sinus
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, symbolizing service to the nation. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1999
Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy Radiologie 4 rue F. Pelloutier Croissy Beaubourg 77437 Marne la Vallee Cedex, 2 FRANCE
Re:
K991455 Panoramic Orthoslice OS1000 series: OS1000, OS1000E, OS1000EC, OS1000P and OS1000EP Dated: April 12, 1999 Received: April 26, 1999 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Ms. Marie-Pierre Labat-Camy:
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 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 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/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) NOTIFICATION
Image /page/1/Picture/1 description: The image shows the logo for Trophy REX Group. The logo features a stylized letter 't' with a circle on its upper right side. Below the 't' is the word "trophy" in a bold, sans-serif font. Underneath "trophy" is the text "REX Group", with "REX" in a bolder font than "Group".
510 (k) Number :
Device Name : OrthoSlice OS1000, OS1000E, OS1000C, OS1000EC
Indication For Use :
The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible.
Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit
The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurence of CDRH, Office of Device Evaluation (ODE)
Daniel h. Symm
Division Sign Off
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use
( Per 21 CFR 801.109 )
Or
Over-The-Counter Use_ ( Optional Format 1-2-96)