(15 days)
The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.
digital x-ray sensor system
This document is a 510(k) premarket notification letter from the FDA to Dentrix Dental Systems, Inc. regarding their ImageRAYi device. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter is a regulatory approval, not a scientific report detailing the clinical validation or performance metrics of the device. It indicates that the device has met the regulatory hurdle of substantial equivalence, which means it is as safe and effective as a legally marketed predicate device. To find the information requested, one would typically need to refer to the 510(k) submission itself, or any associated clinical or performance studies included within that submission, rather than just the FDA's decision letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2004
Dentrix Dental Systems, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K041580 Trade/Device Name: ImageRAYi Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: June 10, 2004 Received: June 14, 2004
Dear Mr. Job:
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 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 (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 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. Brygdon
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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PRE-MARKET NOTIFICATION
INDICATIONS FOR USE
510(k) Number: Koy 1580
Device Name: ImageRAYi, digital x-ray sensor system
Indications for Use: The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use: ________ V
Over the Counter Use: _ (Per 21 CFR 801.109)
David G. Segura
(Division Sign -Off) Abdominal Divis June Fround . ... and Record and a ses 510(k) ... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 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.