(87 days)
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No
The description focuses on digital image capture and basic image processing features, with no mention of AI or ML.
No
The device is used to provide instant images of x-rayed human oral tissue and teeth, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
Explanation: The device provides images of x-rayed human oral tissue and teeth, which are then used for viewing, storage, and printing. While the immediate output is an image, image acquisition for medical assessment of the oral tissue and teeth inherently serves in the diagnostic process.
No
The device description explicitly mentions a "QuickRay DSX 730 sensor device" which is an electronic sensor placed inside the patient's mouth, indicating a hardware component is part of the system.
Based on the provided information, the QuickRay DSX 730 sensor 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. They are used outside of the living body (in vitro).
- QuickRay DSX 730 Function: The QuickRay DSX 730 is an imaging device that captures images of human oral tissue and teeth inside the patient's mouth using X-rays. It is a direct imaging system used in vivo (within the living body).
Therefore, the QuickRay DSX 730 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing.
Product codes
90 MUH
Device Description
The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
x-rayed
Anatomical Site
human oral tissue and teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
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§ 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1999
Claude Berthoin Video Dental Supply 1095 Mason Avenue Daytona Beach, FL 32117 Re:
K990002 QuickRay DSX 730 Dated: December 31, 1998 Received: January 4, 1999 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH
Dear Mr. Berhoin:
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 vours,
J. Daniel O. Schutte, M.D.
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) : K990002
QuickRay DSX 730 DEVICE NAME:
INDICATIONS FOR USE:
The QuickRay DSX 730 sensor device and related components is used to 1) provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.
This is acheived by using the conventional x-ray tube, but by placing 2) an electronic sensor, instead of film, inside the patients mouth. The sensor, un creet only bensorye, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing.
3)Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.
Similar devices have been in use in the USA since 1989, and are now 4) well accepted by Dentists.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-Th
(Opti
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological 510(k) Number
Over-The-Counter-Use (Optional Format 1-2-9