Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616760

FEI Number

3007784465

Entity Name

Change Healthcare Israel Ltd.

City/State/Country

HOLON Central, IL

Establishment Address

26 HAROKMIM ST., AZRIELI CENTER,, BUILDING A, HOLON Central 5885849, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Change Healthcare Israel Ltd (Owner Number: 9029900)

Owner / Operator Contact Address

26 HAROKMIM ST., AZRIELI CENTER, BUILDING A, HOLON, IL-M 5885849, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212528

PMA Number

N/A

All Registered Proprietary Names

McKesson Cardiology Hemo Change Healthcare Cardiology Hemo McKesson Cardiology Change Healthcare Cardiology Hemodynamics Change Healthcare Cardiology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-12-11
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-12-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-09-06
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-12
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-02-27

Official Correspondent

Alona Golik

US Agent Details

Jay Sloman Email: jay.sloman@optum.com Phone: (678) 8600782

Related Public Records

Same Entity

Change Healthcare Israel Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

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3031786139	B-SECUR LIMITED	Belfast, GB
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616760. Last updated year: 2026. Please use registration number 9616760 when referencing this establishment in official correspondence.