ClearanceBrief
Company

Toshiba American Medical Systems Inc

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
97recalls (0 in 12 months)
84recalls that name a 510(k)

Product codes

CodeDeviceRecords
JAKSystem, X-Ray, Tomography, Computed40
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic17
JAASystem, X-Ray, Fluoroscopic, Image-Intensified10
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)7
OWBInterventional Fluoroscopic X-Ray System7
LNHSystem, Nuclear Magnetic Resonance Imaging5
IYOSystem, Imaging, Pulsed Echo, Ultrasonic4
KPSSystem, Tomography, Computed, Emission3
ITXTransducer, Ultrasonic, Diagnostic2
IXRTable, Radiographic, Tilting1
MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 4, 2018Toshiba American Medical Systems Inc
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the
Terminated
IYNK163702
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000H Fluoroscopic X-Ray Systems
Terminated
JAAK082830
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Terminated
OWBK133535
K170909
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000C Fluoroscopic X-Ray Systems
Terminated
OWBK152697
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000F Fluoroscopic X-Ray Systems
Terminated
MBQK081624
Sep 12, 2017Toshiba American Medical Systems Inc
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including gene
Terminated
JAAK133553
May 1, 2017Toshiba American Medical Systems Inc
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Terminated
IYNK161843
May 1, 2017Toshiba American Medical Systems Inc
APLIO 500 TUS-A500 diagnostic ultrasound system
Terminated
IYNK151451
May 1, 2017Toshiba American Medical Systems Inc
APLIO 300 TUS-A300 diagnostic ultrasound system
Terminated
IYNK151451
May 1, 2017Toshiba American Medical Systems Inc
XARIO 200 TUS-X200 diagnostic ultrasound system
Terminated
IYNK162155
May 1, 2017Toshiba American Medical Systems Inc
XARIO 100 TUS-X100 diagnostic ultrasound system
Terminated
IYNK162187
Mar 23, 2017Toshiba American Medical Systems
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky tab
Terminated
MQBK122842
Mar 15, 2017Toshiba American Medical Systems Inc
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy.
Terminated
OWBK170832
Feb 1, 2017Toshiba American Medical Systems Inc
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Terminated
OWBK152785
Nov 18, 2016Toshiba American Medical Systems Inc
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 reconstructi
Terminated
JAKK141741
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Terminated
KPSNone listed
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Terminated
JAKNone listed
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the h
Terminated
JAKNone listed
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Terminated
JAKNone listed
Aug 4, 2016Toshiba American Medical Systems Inc
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Terminated
IYNK143027
K143046
Jul 18, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Terminated
OWBK150967
Jul 6, 2016Toshiba American Medical Systems Inc
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without
Terminated
LNHK152371
May 19, 2016Toshiba American Medical Systems Inc
Toshiba Ultimax DREX-ULT80 X-ray generator
Terminated
JAANone listed
May 19, 2016Toshiba American Medical Systems Inc
Toshiba Kalare DREX-KL80 X-ray generator
Terminated
JAANone listed
May 4, 2016Toshiba American Medical Systems Inc
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). Th
Terminated
KPSK140651
Apr 12, 2016Toshiba American Medical Systems Inc
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
Terminated
JAKK151833
Mar 21, 2016Toshiba American Medical Systems Inc
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating
Terminated
JAAK133553
Feb 9, 2016Toshiba American Medical Systems Inc
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Terminated
OWBK120073
K133535 +2
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-303A
Terminated
JAKK141741
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-302A
Terminated
JAKK120710
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
Terminated
JAKK142465
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301B
Terminated
JAKK120546
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301A
Terminated
JAKK113466
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-101A
Terminated
JAKK080211
Oct 7, 2015Toshiba American Medical Systems Inc
Celesteion PCA-9000A/2 PET/CT System
Terminated
KPSK140651
Apr 6, 2015Toshiba American Medical Systems Inc
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is regi
Terminated
OWBK143225
Nov 26, 2014Toshiba American Medical Systems Inc
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm det
Terminated
JAKK113466
Nov 26, 2014Toshiba American Medical Systems Inc
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector
Terminated
JAKK132222
Jun 4, 2014Toshiba American Medical Systems Inc
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Terminated
MQBK120073
Mar 6, 2014Toshiba American Medical Systems Inc
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Terminated
JAKK132222
Mar 3, 2014Toshiba American Medical Systems Inc
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium
Terminated
JAKK080211
K113466 +1
Nov 13, 2013Toshiba American Medical Systems Inc
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Terminated
LNHK102489
Oct 30, 2013Toshiba American Medical Systems Inc
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Terminated
IYNK091295
Oct 30, 2013Toshiba American Medical Systems Inc
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Terminated
IYNK092948
Oct 30, 2013Toshiba American Medical Systems Inc
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
Terminated
IYNK072918
Oct 30, 2013Toshiba American Medical Systems Inc
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Terminated
IYNK050380
Jul 10, 2013Toshiba American Medical Systems Inc
TOSHIBA Kalare Diagnostic X-Ray System K110785
Terminated
JAAK110785
Apr 12, 2013Toshiba American Medical Systems Inc
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Terminated
ITXNone listed
Apr 11, 2013Toshiba American Medical Systems Inc
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Terminated
LNHK113093
K120638
Apr 8, 2013Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Terminated
JAKK122109

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