(25 days)
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Not Found
No
The summary describes a standard intra-oral X-ray generator and contains no mention of AI, ML, image processing, or any related concepts.
No.
The device is described as an X-ray generator intended for examination and diagnosis, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is intended for "diagnosis of the teeth, jaw and oral structures."
No
The device is described as intra-oral X-ray generators, which are hardware devices. The summary does not mention any software component that functions as a medical device independently of the hardware.
Based on the provided information, the Kodak 2100 and Kodak 2200 intra-oral X-ray generators are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of the teeth, jaw and oral structures." This involves generating images of internal body structures using X-rays.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Modality: The input imaging modality is "intra-oral X-ray," which is an imaging technique applied directly to the patient, not a test performed on a sample outside the body.
Therefore, these devices fall under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
Kodak 2100 and Kodak 2200, intra-oral X-ray generators are intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Product codes
EHD
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
teeth, jaw and oral structures
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Heatth Service
MAR 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager Kodak-Trophy 4 Rue Ferdinand Pelloutier Croissy-Beaubourg, Marne-la-Vallée, Cedex 2, 77437 FRANCE
Re: K060292
Trade/Device Name: Kodak 2100 and Kodak 2200 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: February 2, 2006 Received: February 6, 2006
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 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.
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 (0/5) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brigdon
Naney C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510 (k) Number :
Device Name : Kodak 2100 or Kodak 2200
Indications For Use :
Kodak 2100 and Kodak 2200, intra-oral X-ray generators are intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Prescription Use V (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 )
Concurence of CDRH, Office of Device Evaluation (ODE)
Nancy C. hoagdon
(Division Sign-Division of Reproductive. and Radiological Device 510(k) Number