IMAGEQUEST by VISUAL MED, INC. | FDA 510(k) Summary

ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "ImageQUEST - Communications Software." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on detailed performance metrics from a specific study.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document acts as an approval notice, not a performance study report.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 | 1998

Thomas Mahoney Visual Med. Inc. 3695 Centre Circle Ft. Mill, South Carolina 29715 Re: K974707

ImageQuest - Communications Software Dated: May 4, 1998 Received: May 4, 1998 Regulatory Class: I 21 CFR 892.2020/Procode: 90 LMD

Dear Mr. Mahoney:

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 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 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 (OS) for Medical Devices: General regulation (2) 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 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%) 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 (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. 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): ` イワフイフ△フ

IMAGEQUEST Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974707

Prescription Use (Per 21 CFR 801. 109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.