510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Change Healthcare Israel Ltd.

HOLON Central, IL

Change Healthcare Israel Ltd. appears in FDA device records in HOLON Central, IL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Change Healthcare Israel Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Mckesson Israel , Ltd.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 8 510(k) clearances for Change Healthcare Israel Ltd. between 2012 and 2023. The busiest year on record is 2012, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Change Healthcare Israel Ltd., by decision year
YearClearances
20122
20131
20141
20151
20181
20211
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230881Change Healthcare Cardiology Hemodynamics™MWISubstantially Equivalent
K212528Change Healthcare CardiologyLLZSubstantially Equivalent
K181080McKesson CardiologyLLZSubstantially Equivalent
K151850McKesson CardiologyLLZSubstantially Equivalent
K133534MCKESSON CARDIOLOGY ECG MOBILEDQKSubstantially Equivalent
K131497MCKESSON CARDIOLOGY HEMOMWISubstantially Equivalent
K113515HORIZON CARDIOLOGY ECG MANAGEMENTDQKSubstantially Equivalent
K112720MCKESSON HORIZON CARDIOLOGYLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Change Healthcare Israel Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96167603007784465Change Healthcare Israel Ltd.26 HAROKMIM ST., AZRIELI CENTER,, HOLON Central 5885849 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1490-2019McKesson Cardiology Hemousers 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 have implemented an outbound interface of procedure results.Class IITerminated
Z-1489-2019Horizon Cardiology Hemousers 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 have implemented an outbound interface of procedure results.Class IITerminated
Z-2968-2018McKesson 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.Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.Class IITerminated
Z-0910-2015McKesson 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 devices.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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain