Who is the manufacturer of BARCOMED 2MP2?

Barco N.V. submitted the Traditional clearance for BARCOMED 2MP2 (K000015).

What is the FDA product code for BARCOMED 2MP2?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BARCOMED 2MP2?

510(k) clearance (submission type: Traditional).

BARCOMED 2MP2

K000015 · Barco N.V. · LLZ · Feb 4, 2000 · Radiology

Device Facts

Record ID	K000015
Device Name	BARCOMED 2MP2
Applicant	Barco N.V.
Product Code	LLZ · Radiology
Decision Date	Feb 4, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

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).