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K Number
K032960
Device Name
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
Manufacturer
WIDE CORPORATION
Date Cleared
2003-10-08

(15 days)

Product Code
LLZ
Regulation Number
892.2050
Type
Traditional
Panel
RA
Reference & Predicate Devices
K023322
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The WIDE 2MP TFT LCD Monitor System IF1902A ™s intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

Device Description

The WIDE 2MP TFT LCD Monitor System IF1902A ™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.

AI/ML Overview

This document is a 510(k) summary for the WIDE 2MP TFT LCD Monitor System IF1902A™ and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary primarily focuses on:

  • Device Description: A flat panel hi-resolution LCD monitor system for displaying digital medical images.
  • Intended Use: Displaying and viewing digital medical images for review and analysis by trained medical practitioners.
  • Technological Characteristics: An image display system consisting of computer software and components; does not contact the patient or control life-sustaining devices.
  • Predicate Device: CORNIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322).
  • Conclusion: The device is substantially equivalent to the predicate device.
  • Compliance: States manufacturing in accordance with voluntary and safety standards (UL, FCC, CE, VCC, etc.).

There is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test set.
  3. Number or qualifications of experts used to establish ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a clinical study report detailing performance against specific acceptance criteria.

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).