510(k) K131497 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MCKESSON CARDIOLOGY HEMO
| Applicant | Mckesson Israel , Ltd., Alpharetta GA, US |
| Decision | Substantially Equivalent, Dec 5, 2013 |
| Received | May 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Cardiology Hemo Software Open, Classified |
MWI | None listed |
| Jan 16, 2025 | A L I Technologies Ltd McKesson Cardiology Hemo software Open, Classified |
MWI | None listed |
| Jan 16, 2025 | A L I Technologies Ltd Change Healthcare Cardiology Hemo software Open, Classified |
MWI | None listed |
| Oct 17, 2024 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. Open, Classified |
MWI | None listed |
| Oct 17, 2024 | CHANGE HEALTHCARE CANADA COMPANY McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. Open, Classified |
DQK | None listed |
| Mar 25, 2019 | Change Healthcare Israel Ltd. Horizon Cardiology Hemo Terminated |
DQK | None listed |
| Mar 25, 2019 | Change Healthcare Israel Ltd. McKesson Cardiology Hemo Terminated |
DQK | None listed |
| Mar 12, 2018 | McKesson Israel Ltd. 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 monitorin Terminated |
DQK | None listed |
| Oct 20, 2014 | Mckesson Information Solutions LLC McKesson Cardiology Hemo.
McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessm Terminated |
MWI | None listed |
| Oct 8, 2014 | Mckesson Information Solutions LLC McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.