(30 days)
KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a KODAK X-OMAT Cassette Leadless for Dental Use. This device is a physical radiographic film cassette and not an AI/ML powered medical device. Therefore, the questions related to AI/ML development, such as acceptance criteria based on algorithm performance, expert ground truth establishment, training/test sets, and comparative effectiveness studies with AI, are not applicable to this document.
The document indicates that the device has been found substantially equivalent to legally marketed predicate devices. Its intended use is as a light-tight holder for an intensifying screen and film, used with dental x-ray imaging equipment and an automatic exposure control (AEC) device, to provide a good radiographic image.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Public Health Service
JUL 10 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia B. Lanzoni Associate, Regulatory Affairs Department Eastman Kodak Company Health Imaging Division 343 State Street ROCHESTER NY 14650 Re: K021903
Trade/Device Name: KODAK X-OMAT Cassette Leadless for Dental Use Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: 90 IXA Dated: June 7, 2002 Received: June 10, 2002
Dear Ms. Lanzoni:
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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-459 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-465 |
| Other | (301) 594-469 |
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 Part 807.97). 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
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Attachment 5 - Indications for Use
510(K) Number (if known):
Device Name: KODAK X-OMAT Cassette/Leadless for Dental Use
Indication of use: KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | ✓ | OR | Over-The-Counter | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K021903 |
6/4/02
§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.