BARCO 5MP MAMMO, MODEL MDMG-5221

• K Number: K090603
• Device Name: BARCO 5MP MAMMO, MODEL MDMG-5221
• Manufacturer: BARCO NV
• Date Cleared: 2009-04-22 ( 48 days)
• Product Code: LLZ
• Regulation Number: 892.2050
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The Barco 5MP Mammo device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners.

Device Description

Not Found

AI/ML Overview

I apologize, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a medical device (Barco 5MP Mammo), not a study report or clinical trial results. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data.

The document states that the device is "intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners." This indicates its intended use as a medical display, not an AI-powered diagnostic device.

To answer your request, I would need a document detailing a clinical study or performance evaluation of a device, including its acceptance criteria and results.

Regulation Number and Section

§ 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).