Home GUDID 00198953076873 SenoIris
Primary DI 00198953076873
Brand SenoIris
Company GE MEDICAL SYSTEMS
Model 1
Device description SenoIris 1 SP5 Software and Manuals
Published 2025-11-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00198953076873 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 00198953076873 00198953076873 198953076873 0198953076873
GMDN Terms# Term, Definition table Term Definition Diagnostic x-ray digital imaging system workstation A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.
Regulatory Flags# DUNS number 266062561 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04260456230215 CHILI PACS CHILI GmbH LLZ 2026-09-25 B141MEDISSUITEMRCT20260 Medis Suite MRCT Medis Medical Imaging Systems B.V. LLZ 2026-09-25 00850025268431 Vitrea Advanced Visualization Canon Medical Informatics, Inc. LLZ 2026-09-21 08437021722109 ADAS 3D ADAS3D MEDICAL S.L. LLZ 2026-09-18 07350092810722 Sectra Orthopedic Package Sectra AB LLZ 2026-09-06 00754016387128 ANDI Imeka Solutions Inc LLZ 2026-05-14 00198953059173 ViewPoint GE Healthcare GmbH LLZ 2026-02-27 00817886020677 Joints MEDSTRAT, INC. LLZ 2026-02-16 00817886020660 Joints MEDSTRAT, INC. LLZ 2025-08-09 00817886020653 Joints MEDSTRAT, INC. LLZ 2025-06-27 00860003424841 OrthoGrid Hip Trauma Orthogrid Systems, Inc. LLZ 2025-06-24 00817886020646 Joints MEDSTRAT, INC. LLZ 2025-04-30 00884838127746 Radiology Operations Command Center Console Philips Medical Systems Nederland B.V. LLZ 2025-03-14 00817886020639 Joints MEDSTRAT, INC. LLZ 2025-03-07 00198715251623 BrainSpec Core™ Software BrainSpec Inc. LLZ 2025-02-10 00817886020622 Joints MEDSTRAT, INC. LLZ 2025-02-03 00670082000610 Modus Plan Synaptive Medical Inc LLZ 2025-01-17 00817886020615 Joints MEDSTRAT, INC. LLZ 2024-12-09 00817886020608 Joints MEDSTRAT, INC. LLZ 2024-11-01 00817886020592 Joints MEDSTRAT, INC. LLZ 2024-08-31 00195278753472 ViewPoint GE Healthcare GmbH LLZ 2024-07-15 00817886020585 Joints MEDSTRAT, INC. LLZ 2024-06-08 00817886020578 Joints MEDSTRAT, INC. LLZ 2024-04-12 00817886020561 Joints MEDSTRAT, INC. LLZ 2024-02-10 00817886020554 Joints MEDSTRAT, INC. LLZ 2023-11-13 00350227000520 Eaglesoft PATTERSON TECHNOLOGY CENTER LLZ 2023-10-25 00754016387111 ANDI Imeka Solutions Inc LLZ 2023-09-01 00817886020516 Joints MEDSTRAT, INC. LLZ 2023-05-29 00817886020509 Joints MEDSTRAT, INC. LLZ 2023-04-03 00817886020493 Joints MEDSTRAT, INC. LLZ 2023-03-06