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Sources: EU EUDAMED, US FDA
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MINDWAYS SOFTWARE, INC.
FDA registration
MINDWAYS SOFTWARE, INC.·1 product·🇺🇸 United States
QCT PRO Asynchronous 3D Spine and CTXA-Hip System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM3ASH0·Convenience Kit consisting of
- QCT Pro Asynchr...
QCT PRO Asynchronous 3D Spine and CTXA-Hip System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM4ASH0·Convenience Kit consisting of
- QCT Pro Asynchr...
QCT PRO 3D Volumetric Spine Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0SS0·Convenience Kit consisting of
- QCT Bone Minera...
QCT PRO Asynchronous 3D Spine Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0AS0·Convenience Kit consisting of
- QCT Pro Asynchr...
QCT PRO Asynchronous 3D Spine and CTXA-Hip Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0ASH0·Convenience Kit consisting of
- QCT Pro Asynchr...
QCT PRO 3D Volumetric Spine System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM3SS0·Convenience Kit consisting of
- QCT Bone Miner...
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
QCT PRO 3D Volumetric Spine and CTXA Hip Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0SSH0·Convenience Kit consisting of
- QCT Bone Minera...
CTXA Hip Bone Mineral Densitometer
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...
QCT PRO 3D Volumetric Spine and CTXA Hip System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM3SSH0·Convenience Kit consisting of
- QCT Bone Minera...
Model 4 CT Calibration Phantom
FDA UDI
MINDWAYS SOFTWARE, INC.·B052PHCTM40·Calibration phantom intended for use as an acce...
QCT Bone Mineral Density Analysis Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIQCTPRO0·The method of Quantitative Computed Tomography ...
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
MINDWAYS QCT PRO
FDA Adverse Event
Injury
·MINDWAYS SOFTWARE, INC.·Product code KGI·April 8, 2014
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·November 28, 2012
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·February 20, 2013
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·September 5, 2012
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MWI·September 5, 2012
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013