Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022257

FEI Number

3003757840

Entity Name

CHANGE HEALTHCARE CANADA COMPANY

City/State/Country

RICHMOND British Columbia, CA

Establishment Address

10711 CAMBIE ROAD, RICHMOND British Columbia V6X 3G5, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Change Healthcare Canada Company (Owner Number: 8022257)

Owner / Operator Contact Address

10711 CAMBIE ROAD, RICHMOND, CA-BC V6X 3G5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071584

PMA Number

N/A

All Registered Proprietary Names

Orthoview 7.2 McKesson Radiology Mammography Plus Change Healthcare Mammography Plus Change Healthcare Anatomical AI Change Healthcare Cardiology Change Healthcare Cardiology Hemodynamics McKesson Cardiology TOMTEC-ARENA Change Healthcare Enterprise Viewer Change Healthcare Stratus Imaging Viewer TOMTEC-ARENA McKesson Radiology Change Healthcare Radiology Solutions McKesson Cardiology ECG Management Change Healthcare Cardiology ECG Management ISA CO2 Conserus Enterprise Viewer Change Healthcare Stratus Imaging PACS ECG Electrodes Ambu BlueSensor Corridor4DM Skin Temperature Probe, Small Skin Temperature Probe, Large General Purpose Rectal/Esophageal Probe, Medium Skin Temperature Probe, Medium General Purpose Rectal/Esophageal Probe, Large Oasis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-05-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-02-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-08-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-02-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-02-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-01-30
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-08-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-02-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-12
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-05-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-07-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-09-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-09-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-07-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-10-17
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-10-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-10-17
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-10-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-08-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-01-26
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2020-12-21
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-12-21
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2020-12-21
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-12-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-12-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-21
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-12-21
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2020-12-21
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-12-21
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-12-21
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2020-12-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-12-21
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-12-21
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2020-12-21
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-12-21
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-12-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-12-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-12-21
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-12-21
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-12-21
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-12-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-03-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-07-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-09-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-07-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-07-31
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-05-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-09-01
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-09-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-09-01
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2013-08-19
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-08-19
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2013-08-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-08-19
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-08-19
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-08-19
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-08-19
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2017-05-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-09-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-26

Official Correspondent

Alona Golik

US Agent Details

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

Related Public Records

Same Entity

Change Healthcare Canada Company

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022257. Last updated year: 2026. Please use registration number 8022257 when referencing this establishment in official correspondence.