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Sources: EU EUDAMED, US FDA
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The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 20, 2012
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 7, 2018
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code OFX·December 11, 2019
Brilliance iCT Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 10, 2015
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 24, 2016
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 7, 2012
SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019
SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·August 21, 2013
SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019
SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016