Data / Medical devices / Israel / Change Healthcare Israel Ltd.
Change Healthcare Israel Ltd.: FDA-registered device maker in HOLON Central, Israel, 6 510(k) clearances
Change Healthcare Israel Ltd. is registered with the FDA (registration 9616760) in HOLON Central, Israel. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 11, 2023. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9616760
- FEI number
- 3007784465
- Address
- 26 Harokmim ST., Azrieli Center, Building A, HOLON Central, Israel, 5885849
- Owner or operator
- Change Healthcare Israel Ltd (9029900)
- Roles
- Specification developer
- First device listed
- December 25, 2012
- Registered through
- 2027
- Brand names listed
- Change Healthcare Cardiology, Change Healthcare Cardiology ECG Management, Change Healthcare Cardiology Hemo, Change Healthcare Cardiology Hemodynamics, McKesson Cardiology, McKesson Cardiology ECG Management, McKesson Cardiology Hemo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2023 | K230881 | Change Healthcare Cardiology Hemodynamics | MWI | Substantially Equivalent | Change Healthcare Israel , Ltd. | accessdata.fda.gov |
| October 18, 2021 | K212528 | Change Healthcare Cardiology | LLZ | Substantially Equivalent | Change Healthcare Israel , Ltd. | accessdata.fda.gov |
| May 24, 2018 | K181080 | McKesson Cardiology | LLZ | Substantially Equivalent | Change Healthcare Israel , Ltd. | accessdata.fda.gov |
| August 11, 2015 | K151850 | McKesson Cardiology | LLZ | Substantially Equivalent | Mckesson Israel , Ltd. | accessdata.fda.gov |
| December 5, 2013 | K131497 | MCKESSON CARDIOLOGY HEMO | MWI | Substantially Equivalent | Mckesson Israel , Ltd. | accessdata.fda.gov |
| March 16, 2012 | K113515 | HORIZON CARDIOLOGY ECG MANAGEMENT | DQK | Substantially Equivalent | Mckesson Israel , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2019 | 82600 | Class II | Terminated | Horizon Cardiology Hemo | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who h | accessdata.fda.gov |
| March 12, 2018 | 80723 | Class II | Terminated | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acqui | Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals. | accessdata.fda.gov |
| December 19, 2014 | 70144 | Class II | Terminated | McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG d | An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Computer, Diagnostic, Programmable
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated September 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.