Home GUDID 00863520000390 Simpleware ScanIP Medical
Primary DI 00863520000390
Brand Simpleware ScanIP Medical
Company SYNOPSYS, INC.
Model S-2021.06 onwards
Device description Final software release for UDI-DI: T-2022.03.Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
Published 2021-06-07
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 00863520000390 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00863520000390 00863520000390 863520000390 0863520000390
GMDN Terms# Term, Definition table Term Definition Radiology 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. It is designed specifically for use within radiology.
Regulatory Flags# DUNS number 161499579 Device count 1 Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M722CD26127V260970 ClearRead CT Docker Riverain Technologies, Inc. LLZ 2026-05-28 17540262200096 Change Healthcare Stratus Imaging Diagnostic Viewer Change Healthcare Canada Company LLZ 2026-05-27 75401622522101 Synthesis Vision Viewer Synthesis Health Intelligence Inc LLZ 2026-05-27 08437021722093 ADAS 3D ADAS3D MEDICAL S.L. LLZ 2026-05-12 08800133400003 ZeTTA PACS Tae Young Soft Co., Ltd. LLZ 2026-05-12 08033837938835 no brand CEFLA SOCIETA' COOPERATIVA LLZ 2026-05-11 G725QFR300 QFR QFR Solutions B.V. LLZ 2026-05-11 G725QFR310 QFR QFR Solutions B.V. LLZ 2026-05-11 08800130800080 Laon Ortho Laon Medi Inc. LLZ 2026-05-07 G713ELU0010 Elucis Realize Medical Inc. LLZ 2026-05-07 08437021468045 QP-BrainĀ® QUIBIM SOCIEDAD LIMITADA. LLZ 2026-05-06 08437023642016 NemoCast SOFTWARE NEMOTEC SL LLZ 2026-04-23 08437023642023 NemoFAB SOFTWARE NEMOTEC SL LLZ 2026-04-23 M722C26103V260970 ClearRead CT Server Riverain Technologies, Inc. LLZ 2026-04-20 M722CC26103V260970 ClearRead CT Console Riverain Technologies, Inc. LLZ 2026-04-20 M722CD26103V260970 ClearRead CT Docker Riverain Technologies, Inc. LLZ 2026-04-20 M722CP26104V261040 ClearRead CT Platform Docker Riverain Technologies, Inc. LLZ 2026-04-20 EOLENEUROINSIGHTV1P00 Neuro Insight Olea Medical USA LLZ 2026-04-13 EOLENEUROVASIV1P00 Neurovascular Insight Olea Medical USA LLZ 2026-04-13 08056304455864 Caas Qardia Pie Medical Imaging B.V. LLZ 2026-04-03 08800290066784 EVO Q10 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. LLZ 2026-04-03 08800340506147 EVO QH10 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. LLZ 2026-04-03 08800340509988 EVO XQ10 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. LLZ 2026-04-03 08800066200619 JLK-AILINK JLK, Inc. LLZ 2026-03-25 08800066200787 JLK-CTP JLK, Inc. LLZ 2026-03-25 08800066200794 JLK-PWI JLK, Inc. LLZ 2026-03-25 08800130400303 Neurophet AQUA AD Plus NEUROPHET Inc. LLZ 2026-02-24 08800290027471 EV2-12 SAMSUNG MEDISON CO., LTD. LLZ 2026-01-28 08800290041767 EA2-11AV SAMSUNG MEDISON CO., LTD. LLZ 2026-01-28 08800290041811 EA2-11AR SAMSUNG MEDISON CO., LTD. LLZ 2026-01-28