172 results
·
68ms
·
Sources: EU EUDAMED, US FDA
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·May 11, 2016
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·October 25, 2016
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·August 24, 2016
Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·October 1, 2010
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code ITX·December 19, 2006
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·May 4, 2016
Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011
Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011
TOSHIBA
FDA Adverse Event
Injury
·TOSHIBA AMERICAN MEDICAL SYSTEMS·Product code LNH·May 25, 2010
TOSHIBA IMAGING TABLE
FDA Adverse Event
Death
·TOSHIBA AMERICAN MEDICAL SYSTEM·Product code IYX·July 16, 2003
TOSHIBA
FDA Adverse Event
Malfunction
·TOSHIBA AMERICAN MEDICAL SYSTEMS·Product code IZO·July 16, 1998
TOSHIBA
FDA Adverse Event
Malfunction
·TOSHIBA AMERICAN MEDICAL SYSTEMS·Product code IZO·July 16, 1998
TOSHIBA
FDA Adverse Event
Injury
·TOSHIBA AMERICAN MEDICAL SYSTEMS·Product code IZO·October 30, 1998
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·August 4, 2016
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code KPS·April 24, 2016
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·November 14, 2012
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 30, 2016
CAT-350B TABLE, CPU CONTROL, W/STEP PIVOT
FDA Adverse Event
Injury
·TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.·Product code KXJ·January 26, 2006
DIGITAL FLUOROSCOPY SYSTEM
FDA Adverse Event
Other
·TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.·Product code IZG·October 15, 1998
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 13, 2008