GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

FDA Device Registration & Listing · Wauwatosa, WI, US · Registration 3005860720

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005860720
FEI Number
3005860720
Entity Name
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
City/State/Country
Wauwatosa, WI, US
Establishment Address
9900 Innovation Drive, Wauwatosa, WI 53226, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
GE HealthCare Technologies Inc. (Owner Number: 9912004)
Owner / Operator Contact Address
3000 N. Grandview Blvd, Waukesha, WI 53188, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K173555
PMA Number
N/A

All Registered Proprietary Names

12S-RS L8-18i-RS L12n-RS 9L-RS L4-20t-RS Venue 12L-RS E8C-RS 6S-RS 3Sc-RS ML6-15-RS 8C-RS L4-12t-RS 6Tc-RS C1-5-RS L10-22-RS Venue Trident Invenia ABUS Workstation Invenia ABUS Invenia ABUS Scan Station Invenia ABUS Review Software ABUS Single-Use Stabilization Membrane - non Sterile Invenia ABUS 2 Invenia ABUS Prime Invenia ABUS Premium 3Sc-RS 6S-RS 12L-RS E8C-RS L4-20t-RS L4-12t-RS 9L-RS Venue Fit ML6-15-RS 8C-RS L10-22-RS C1-5-RS L8-18i-RS 6Tc-RS 12S-RS E8C-RS L8-18i-RS 6Tc-RS 9L-RS 3Sc-RS L4-12t-RS 8C-RS C1-5-RS 12L-RS Venue Go 6S-RS L8-18i-D P6D LOGIQ E10 C1-6VN-D C3-10-D RIC5-9-D C1-6-D M5Sc-D 6S-D IC5-9-D 6Tc-RS L2-9VN-D ML6-15-D L2-9-D BE9CS-D RAB6-D P2D C2-9VN-D C2-9-D 12L-RS L10-22-RS ML6-15-RS 12S-RS L8-18i-RS 8C-RS L4-20t-RS C1-5-RS 3Sc-RS Venue Fit M5Sc-RS 9L-RS L4-12t-RS 6Tc-RS 6S-RS E8C-RS C2-9VN-D C1-6-D LOGIQ E10 IC5-9-D L4-20t-D M5Sc-D L8-18i-D ML4-20VN-D L2-9-D C3-10-D 6S-D BE9CS-D 6Tc-RS P2D C1-6VN-D L2-9VN-D RIC5-9-D RAB6-D C2-9-D L3-12-D ML4-20-D ML6-15-D P6D L4-20t-RS L10-22-RS 9L-RS Venue Go 8C-RS E8C-RS L8-18i-RS 3Sc-RS 6S-RS ML6-15-RS L4-12t-RS M5Sc-RS 12L-RS 6Tc-RS 12S-RS C1-5-RS L12n-RS C1-5-RS 8C-RS 12L-RS E8C-RS 3Sc-RS 9L-RS Venue L8-18i-RS C1-5-RS L4-12t-RS 12L-RS L10-22-RS Venue Go E8C-RS 9L-RS 8C-RS 6S-RS 3Sc-RS 12S-RS ML6-15-RS L4-20t-RS 6Tc-RS L2-9-D L8-18i-D ML6-15-D 6Tc-RS L2-9VN-D C1-6-D C3-10-D M5Sc-D C2-9-D LOGIQ E10 RAB6-D IC5-9-D RIC5-9-D C2-9VN-D P2D C1-6VN-D

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-16
PAA Automated Breast Ultrasound Unknown Class 3 N/A 2013-02-11
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-01-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-01-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-01-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-11-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-11-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-11-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-06-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007120336 GE Healthcare Magyarorszag Kft. Budapest, HU
3015060224 IMACTIS, SAS SAINT MARTIN D'HERES, FR
2122726 GE MEDICAL SYSTEMS, LLC Milwaukee, WI, US
9617766 GE BE PRIVATE LIMITED WHITEFIELD, BANGALORE Karnataka, IN
9710090 GE ULTRASOUND KOREA, LTD. Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005860720. Last updated year: 2026. Please use registration number 3005860720 when referencing this establishment in official correspondence.
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