9 results
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43ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
FDA Enforcement
Class II
·Terminated·Konica Minolta, Inc.·August 2, 2017
Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.
FDA Enforcement
Class II
·Terminated·Konica Minolta Healthcare, Americas, Inc.·December 26, 2018
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
FDA Enforcement
Class II
·Terminated·Konica Minolta Healthcare Americas, Inc.·January 26, 2022
ImagePilot, Model No. D9MA
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·July 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
CS-7, Model No. A4C1
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·July 4, 2018