DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
Applicant
Trex Medical Corp.
Product Code
LLZ · Radiology
Decision Date
Sep 10, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Indications for Use
Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be Digital Imaging System, Model Digi REA-Koo 15 a alghar Was a produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.
Device Story
The DigiTrex-1000 and DigiTrex-2000 are digital video processing systems designed to interface with radiographic, fluoroscopic, or special procedure imaging equipment. The device accepts analog video signals from these imaging systems, digitizes the input, and performs image processing to enhance or manage the output for clinical review. It is intended for use in clinical settings by healthcare professionals to facilitate the visualization of diagnostic images. The system does not include mammography applications. By converting and processing video signals, the device allows for improved image handling and display, supporting clinical decision-making in diagnostic radiology and special procedures.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Digital video processing system; inputs analog video signals from radiographic/fluoroscopic systems; performs digital conversion and image processing; standalone system; intended for professional clinical use.
Indications for Use
Indicated for digital video processing of images produced by radiographic, fluoroscopic, or special procedure systems, excluding mammography.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
William T. Cousins Vice President Regulatory Affairs Trex Medical Corporation Continental Subsidiary 2000 South 25th Avenue Broadview, IL 60153
Re:
K982120 Digitrex-1000 and Digitrex-2000 Dated: June 5, 1998 Received: June 16, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Cousins:
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, against misbranding and adulteration.
If your device is classified (see above) into either class II (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 equivalion 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 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 (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/cdch/dsmaldsmamain.html".
Sincerely yours,
Lillian Yiz, 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): K982120
DEVICE NAME: DigiTrex-1000 and DigiTrex-2000
INDICATIONS FOR USE:
Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be Digital Imaging System, Model Digi REA-Koo 15 a alghar Was a produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
David G. Symons
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number .
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