Home GUDID 03700719700419 MYRIAN
Primary DI 03700719700419
Brand MYRIAN
Company INTRASENSE
Model MYRIAN 2.4
Device description Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Published 2018-07-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LLZ System, Image Processing, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLZ System, Image Processing, Radiological Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03700719700419 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03700719700419 03700719700419 3700719700419
GMDN Terms# Term, Definition table Term Definition Radiological PACS software An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.
Regulatory Flags# DUNS number 272423299 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198953246405 Xeleris V Processing and Review System G E MEDICAL SYSTEMS ISRAEL LTD. LLZ 2026-08-03 00860011624349 IntraOpVSP Xironetic LLC LLZ 2026-08-03 00862234000337 Mosaic Viewer Virtual Radiologic Corporation LLZ 2026-07-31 09358140000093 Quicktome Software Suite Omniscient Neurotechnology Pty Ltd (o8t) LLZ 2026-07-30 00866463000496 STAGE Spintech, Inc. LLZ 2026-07-23 00854810007229 iCRco Clarity Viewer IcRco, Inc. LLZ 2026-07-22 17540262200102 Change Healthcare Stratus Imaging Diagnostic Viewer Change Healthcare Canada Company LLZ 2026-07-22 17540262090161 Change Healthcare Cardiology Change Healthcare Canada Company LLZ 2026-07-21 M722CP26183V261830 ClearRead CT Platform Docker Riverain Technologies, Inc. LLZ 2026-07-17 00854393006084 Velocity VARIAN MEDICAL SYSTEMS, INC. LLZ 2026-07-16 G874AVARAVIEWER0010 Avara Viewer AVARA SOFTWARE LLC LLZ 2026-07-13 06938396401528 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401559 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401566 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401597 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401603 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401634 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401658 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401702 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396401719 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 06938396410124 SIUI Shantou Institute of Ultrasonic Instruments Co., Ltd. LLZ 2026-07-10 04260483290305 MeVis AVM Contour MeVis Medical Solutions AG LLZ 2026-07-09 G775EVOLVE4140 EVOLVE Smaart Medical Systems, Inc. LLZ 2026-07-09 08056304456205 3mensio Workstation Pie Medical Imaging B.V. LLZ 2026-07-08 00850059977576 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-07-03 00850059977583 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-07-03 00850059977590 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-07-03 00850059977606 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-07-03 00850059977613 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-07-03 00850059977521 TIMS System FORESIGHT IMAGING, LLC LLZ 2026-06-26