MCKESSON CARDIOLOGY HEMO— 510(k) K131497
Substantially EquivalentMckesson Israel , Ltd.
FDA 510(k) clearance K131497 for MCKESSON CARDIOLOGY HEMO, Substantially Equivalent on 2013-12-05. Applicant: Mckesson Israel , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mckesson Israel , Ltd.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code MWI
view allMore clearances from Mckesson Israel , Ltd.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131497
K-number listed on FDA's recall record- Z-2071-2025 — Change Healthcare Cardiology Hemo Software
- Z-0957-2025 — McKesson Cardiology Hemo software
- Z-0958-2025 — Change Healthcare Cardiology Hemo software
- Z-0126-2025 — Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
- Z-0128-2025 — McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
- Z-1489-2019 — Horizon Cardiology Hemo
- Z-1490-2019 — McKesson Cardiology Hemo
- Z-2968-2018 — 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 acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
- Z-0042-2015 — McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Z-0093-2015 — McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131497.
Data sourced from openFDA. This site is unofficial and independent of the FDA.