(168 days)
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No
The summary describes a digital intraoral X-ray system with wireless transmission and an "Intelligent Positioning System," but there is no mention of AI, ML, image processing beyond basic acquisition, or any data sets or performance metrics typically associated with AI/ML algorithms. The "Intelligent Positioning System" likely refers to a non-AI/ML based alignment mechanism.
No
The device is used for diagnostic purposes (replacing X-ray film for intraoral diagnostic purposes), not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the system is "intended to replace dental Xray film for any intraoral diagnostic purposes," explicitly indicating its use for diagnosis.
No
The device description explicitly mentions a "wireless digital intraoral system" and a "RVG sensor," which are hardware components. It also states it uses wireless technology to transmit images, implying a physical sensor is acquiring the image.
Based on the provided information, the Kodak RVG 6500 wireless digital intraoral system 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 Kodak RVG 6500 system is used to acquire digital X-ray images directly from within the patient's mouth (intraoral). It replaces traditional X-ray film for diagnostic purposes.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the patient. It captures images of the patient's anatomy.
Therefore, the Kodak RVG 6500 system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kodak RVG 6500 wireless digital intraoral system is intended to replace dental Xray film for any intraoral diagnostic purposes. It uses the wireless technology in order to transmit the acquire image to a computer. It requires additional components such as conventional extraoral X-ray source and visualization software
The Kodak RVG 6500 IPS System, in addition, provides the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor.
Product codes
MUH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
intraoral
Indicated Patient Age Range
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Intended User / Care Setting
dentist
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)
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Reference Device(s)
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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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy, A Subsidiary of Carestream Health, Inc. 4, rue F.Pelloutier-Croissy-Beaubourg 77435 Marne La Vallée Cedex 2 FRANCE
APR 2 6 2010
Re: K093478
Trade/Device Name: Kodak RVG 6500 System and Kodak RVG 6500 IPS System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 10, 2010 Received: March 10, 2010
Dear Ms. Labat-Camy:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director . Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Traditional 510 (k): Kodak RVG 6500 and Kodak RVG 6500 IPS
INDICATIONS FOR USE
510 (k) Number :
Device Name : Kodak RVG 6500 System Kodak RVG 6500 IPS System
Indications For Use :
The Kodak RVG 6500 wireless digital intraoral system is intended to replace dental Xray film for any intraoral diagnostic purposes. It uses the wireless technology in order to transmit the acquire image to a computer. It requires additional components such as conventional extraoral X-ray source and visualization software
The Kodak RVG 6500 IPS System, in addition, provides the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor.
Prescription Use __ (21 CFR 801 Subpart D )
and/or
Over-The-Counter Use ( 21 CFR 801 Subpart C )
( Please do not write below this line - Continue on another page if needed )
b
Concurence of CDRH, Office of Device Evaluation (ODE) C
(Division Sign On
Office of In
510K