(57 days)
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#K-12439
No
The document describes image processing capabilities but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is used to acquire instant x-ray images and enhance them for diagnostic purposes, not to treat a condition.
No
The device is described as an X-ray conversion kit that captures images of oral tissue and teeth. While these images are used by clinicians for diagnosis, the device itself is an imaging device that provides the images, rather than directly performing a diagnostic function or providing a diagnostic output. Its primary function is to convert X-ray data into digital images for viewing and post-processing.
No
The device description explicitly states it is a "sensor connected to the DentalEye software," indicating a hardware component (the sensor) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- This device is an imaging device that captures X-ray images of the human oral tissue and teeth. It directly images the patient's anatomy rather than analyzing a biological sample.
The description clearly indicates it's a digital X-ray conversion kit used for obtaining images of the patient's oral structures. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RetroPan CCD -- TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
Product codes
MUH
Device Description
The RetroPan CCD - TWAIN - USB sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-12439, which gives post processing capabilities to enhance images. It is faster to obtain images with the RetroPan CCD – TWAIN – USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 24 2007
Mr. Claude Berthoin President/Owner Video Dental Concepts, Inc. 110 East Granada Boulevard, Suite 207 ORMOND BEACH FL 32176
Re: K070535
Trade/Device Name: RetroPan CCD - Twain - USB Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 21, 2007 Received: February 26, 2007
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 enactively device Nedical 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, controls provision of 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font, with three stars underneath. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
1
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication For Use
Applicant: Video Dental Concepts, Inc.
070535 510(k) Number (if known):
Device Name: RetroPan CCD – TWAIN - USB
Indication for use: The RetroPan CCD -- TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
The RetroPan CCD - TWAIN - USB sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-12439, which gives post processing capabilities to enhance images.
It is faster to obtain images with the RetroPan CCD – TWAIN – USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K070535 |
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