(85 days)
Not Found
No
The summary describes a digital radiography system that captures and displays images, but there is no mention of AI or ML for image analysis, interpretation, or other functions.
No.
The device is used for diagnostic imaging (capturing images of x-rayed tissue), not for treating a condition or disease.
No
The device provides images of x-rayed tissue and teeth, which are then used for viewing, storage, printing, and manipulation of the x-rays. This describes an imaging system, not a device that directly provides a diagnosis. Diagnostic information would need to be extracted from these images by a healthcare professional.
No
The device description explicitly mentions an "electronic sensor" placed inside the patient's mouth, which is a hardware component. The software processes images captured by this sensor.
No, 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 samples) to provide information about a person's health. This testing is done outside the body (in vitro).
- RSV Device Function: The RSV device works by capturing images of oral tissue and teeth inside the patient's mouth using an electronic sensor and X-rays. This is an in vivo imaging process, not an in vitro diagnostic test.
The device is a medical imaging system used for diagnostic purposes, but it falls under the category of radiology equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.
Product codes
EHD
Device Description
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human oral tissue and teeth
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)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
JUL 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Claude D. Berthoin President VideoDental Concepts 110E Granada Blvd. Suite 207 & 208, P.O. Box 36 ORMOND BEACH FL 32175-0036 Re: K031448
Trade/Device Name: RSV (Radiology System Visiodent) Device Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: 90 EHD Dated: July 14, 2003 Received: July 21, 2003
Dear Mr. Berthoin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
510(k) Number (if known): K031448
Device Name: ___________ RSV (Radiology System Visiodent
Indications For Use:
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.
RSV is therefore similar to Trophy's RVG and Video Dental Concept's QuickRay and several other legal systems, in its intended use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
David A. Ingram
Reproductive, Abdomina
Over-The Counter Use
(Optional Format 1-2-96)