149 results
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86ms
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Sources: EU EUDAMED, US FDA
RADIOLOGY INFORMATION SYSTEMS, INC.
FDA registration
RADIOLOGY INFORMATION SYSTEMS, INC.·4 products·🇺🇸 United States
Radiology Information Systems, Inc.
FDA UDI
Radiology Information Systems, Inc.·00860009490604·PowerDR Console Application is an X-ray digital...
Radiology Information Systems, Inc.
FDA UDI
Radiology Information Systems, Inc.·00860009490642·For use as a storage and display node on a DICO...
Radiology Information Systems, Inc.
FDA UDI
Radiology Information Systems, Inc.·00860009490628·Software module capable of taking an x-ray imag...
DAVINCI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 2, 2022
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2013
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 1, 2016
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·January 9, 2025
FDR GO
FDA Adverse Event
Death
·SHIMADZU CORPORATION·Product code IZL·July 17, 2017
DA VINCI SP
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2026
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013
DRX-EVOLUTION PLUS AUTOMATIC - DUAL BUCK
FDA Adverse Event
Malfunction
·CARESTREAM HEALTH INC.·Product code KPR·February 6, 2022
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·November 12, 2024
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 15, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 1, 2016
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·November 1, 2013
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·November 1, 2013
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 3, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 29, 2016
MATTA PELVIC SYSTEM
FDA Adverse Event
Death
·STRYKER·Product code HRS·August 12, 2023