Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183066

FEI Number

2183066

Entity Name

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

City/State/Country

MADISON, WI, US

Establishment Address

3030 Ohmeda Drive, MADISON, WI 53718, 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

Expiration Date (Year)

2026

510(k) Number

K133664

PMA Number

N/A

All Registered Proprietary Names

Lunar Astra Aria Aria X-Ray Bone Densitometer Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix GEHC DXA Bone Densitometers with enCORE version 18 Prodigy Primo Prodigy Pro Compact Prodigy Advance Lunar iDXA Prodigy Pro Prodigy Primo Compact Prodigy Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Prodigy Pro Prodigy Prodigy Advance Prodigy Primo Prodigy GE Lunar DXA Bone Densitometers with enCORE version 16 Lunar iDXA iDXA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2026-06-18
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2018-04-22
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2004-09-24
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2019-10-08
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2014-12-02
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2007-10-16
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2014-09-08

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
K983273	Medical Systems, Inc.	XCT 2000 L PQCT BONE DENSITOMETER	1998-10-29
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2008	Datex Ohmeda, Inc	1	GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
Z-0021-2007	Datex Ohmeda, Inc	2	GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
Z-0037-06	Datex-Ohmeda Inc	2	Datex-Ohmeda S/5 Aespire Anesthesia System 7100
Z-0038-06	Datex-Ohmeda Inc	2	Datex-Ohmeda S/5 Aespire Anesthesia System 7900
Z-0039-06	Datex-Ohmeda Inc	2	Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183066. Last updated year: 2026. Please use registration number 2183066 when referencing this establishment in official correspondence.