QUICKRAY DSX 730

• K Number: K990002
• Device Name: QUICKRAY DSX 730
• Manufacturer: JULIE ALLIANCE
• Date Cleared: 1999-04-01 ( 87 days)
• Product Code: MUH
• Regulation Number: 872.1800
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K061114 , K080738

Intended Use

The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.

Device Description

The QuickRay DSX 730 sensor device and related components. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.

AI/ML Overview

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the QuickRay DSX 730 device. This device is a digital X-ray sensor for capturing images of human oral tissue and teeth, replacing conventional film.

Unfortunately, neither of these documents contains information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it has met regulatory requirements for market clearance, not necessarily performance-based acceptance criteria from a specific study.

Therefore, I am unable to provide the requested information based on the input text. The documents do not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1999

Claude Berthoin Video Dental Supply 1095 Mason Avenue Daytona Beach, FL 32117 Re:

K990002 QuickRay DSX 730 Dated: December 31, 1998 Received: January 4, 1999 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Berhoin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours,

J. Daniel O. Schutte, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : K990002

QuickRay DSX 730 DEVICE NAME:

INDICATIONS FOR USE:

The QuickRay DSX 730 sensor device and related components is used to 1) provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.

This is acheived by using the conventional x-ray tube, but by placing 2) an electronic sensor, instead of film, inside the patients mouth. The sensor, un creet only bensorye, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing.

3)Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.

Similar devices have been in use in the USA since 1989, and are now 4) well accepted by Dentists.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-Th
(Opti

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,

(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological 510(k) Number

Over-The-Counter-Use (Optional Format 1-2-9

Regulation Number and Section

§ 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.