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CAAS II QVA

FDA 510(k)
FDA Class 2 ·Radiology

DLX M25.16 SW PACKAGE

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS SCS·Product code IZI·September 15, 2005

CAAS QVA 3D, CAAS QCA 3D

FDA 510(k)
FDA Class 2 ·Radiology

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code FGE·May 29, 2014

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 23, 2020

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020

ARTIS ICONO BIPLANE

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH- AT·Product code OWB·March 24, 2020

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·REFLEXION MEDICAL, INC·Product code QVA·July 1, 2025

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL, INC.·Product code QVA·May 27, 2025

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 3, 2026

REFLEXION MEDICAL RADIOTHERAPY SYSTEM

FDA Adverse Event
Injury ·REFLEXION MEDICAL INC·Product code QVA·April 1, 2026