12 results
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41ms
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Sources: EU EUDAMED, US FDA
Bot Image, Inc.
Manufacturer
🇺🇸 United States
BOT IMAGE, INC.
FDA registration
BOT IMAGE, INC.·1 product·🇺🇸 United States
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082625·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082618·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082601·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·February 14, 2022
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 18, 2016
iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·August 29, 2008
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Enforcement
Class II
·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017
Umedwings Netherlands B.V.
Importer
🇳🇱 Netherlands·36 Manufacturers
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices