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
| Code | Device | Records |
|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 40 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 17 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 10 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 7 |
| OWB | Interventional Fluoroscopic X-Ray System | 7 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 |
| KPS | System, Tomography, Computed, Emission | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| IXR | Table, Radiographic, Tilting | 1 |
| MBQ | Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2018 | Toshiba 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 |
IYN | K163702 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000H Fluoroscopic X-Ray Systems Terminated |
JAA | K082830 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM Terminated |
OWB | K133535 K170909 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000C Fluoroscopic X-Ray Systems Terminated |
OWB | K152697 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000F Fluoroscopic X-Ray Systems Terminated |
MBQ | K081624 |
| Sep 12, 2017 | Toshiba 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 |
JAA | K133553 |
| May 1, 2017 | Toshiba American Medical Systems Inc APLIO i-series:
a) APLIO i700 TUS AI700
b) APLIO i800 TUS AI800
diagnostic ultrasound system Terminated |
IYN | K161843 |
| May 1, 2017 | Toshiba American Medical Systems Inc APLIO 500 TUS-A500
diagnostic ultrasound system Terminated |
IYN | K151451 |
| May 1, 2017 | Toshiba American Medical Systems Inc APLIO 300 TUS-A300
diagnostic ultrasound system Terminated |
IYN | K151451 |
| May 1, 2017 | Toshiba American Medical Systems Inc XARIO 200 TUS-X200
diagnostic ultrasound system Terminated |
IYN | K162155 |
| May 1, 2017 | Toshiba American Medical Systems Inc XARIO 100 TUS-X100
diagnostic ultrasound system Terminated |
IYN | K162187 |
| Mar 23, 2017 | Toshiba 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 |
MQB | K122842 |
| Mar 15, 2017 | Toshiba 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 |
OWB | K170832 |
| Feb 1, 2017 | Toshiba American Medical Systems Inc Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F Terminated |
OWB | K152785 |
| Nov 18, 2016 | Toshiba 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 |
JAK | K141741 |
| Oct 6, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner Terminated |
KPS | None listed |
| Oct 6, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner Terminated |
JAK | None listed |
| Oct 6, 2016 | Toshiba 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 |
JAK | None listed |
| Oct 6, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. Terminated |
JAK | None listed |
| Aug 4, 2016 | Toshiba American Medical Systems Inc Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. Terminated |
IYN | K143027 K143046 |
| Jul 18, 2016 | Toshiba 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 |
OWB | K150967 |
| Jul 6, 2016 | Toshiba 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 |
LNH | K152371 |
| May 19, 2016 | Toshiba American Medical Systems Inc Toshiba Ultimax DREX-ULT80 X-ray generator Terminated |
JAA | None listed |
| May 19, 2016 | Toshiba American Medical Systems Inc Toshiba Kalare DREX-KL80 X-ray generator Terminated |
JAA | None listed |
| May 4, 2016 | Toshiba 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 |
KPS | K140651 |
| Apr 12, 2016 | Toshiba 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 |
JAK | K151833 |
| Mar 21, 2016 | Toshiba 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 |
JAA | K133553 |
| Feb 9, 2016 | Toshiba American Medical Systems Inc INFX-8000V Bi-Plane X-Ray Interventional System
X-ray systems Terminated |
OWB | K120073 K133535 +2 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-303A Terminated |
JAK | K141741 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-302A Terminated |
JAK | K120710 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301C Terminated |
JAK | K142465 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301B Terminated |
JAK | K120546 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301A Terminated |
JAK | K113466 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-101A Terminated |
JAK | K080211 |
| Oct 7, 2015 | Toshiba American Medical Systems Inc Celesteion PCA-9000A/2 PET/CT System Terminated |
KPS | K140651 |
| Apr 6, 2015 | Toshiba 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 |
OWB | K143225 |
| Nov 26, 2014 | Toshiba 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 |
JAK | K113466 |
| Nov 26, 2014 | Toshiba 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 |
JAK | K132222 |
| Jun 4, 2014 | Toshiba 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 |
MQB | K120073 |
| Mar 6, 2014 | Toshiba American Medical Systems Inc TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Terminated |
JAK | K132222 |
| Mar 3, 2014 | Toshiba 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 |
JAK | K080211 K113466 +1 |
| Nov 13, 2013 | Toshiba American Medical Systems Inc Titan 3T MRI System, MRT-3010A/5.
Product Usage: Usage:
MRI system. Terminated |
LNH | K102489 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Aplio XG Diagnostic Ultrasound System SSA-790A
Used for routine diagnostic imaging Terminated |
IYN | K091295 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Aplio MX Diagnostic Ultrasound System SSA-780A
Used for routine diagnostic imaging Terminated |
IYN | K092948 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Xario XG Diagnostic Ultrasound System SSA-680A
Used for routine diagnostic imaging Terminated |
IYN | K072918 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Xario Diagnostic Ultrasound System SSA-660A
Used for routine diagnostic imaging Terminated |
IYN | K050380 |
| Jul 10, 2013 | Toshiba American Medical Systems Inc TOSHIBA Kalare Diagnostic X-Ray System
K110785 Terminated |
JAA | K110785 |
| Apr 12, 2013 | Toshiba American Medical Systems Inc Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300).
Device Listing Number: Dl53118.
Diagnostic Ultrasound system. Terminated |
ITX | None listed |
| Apr 11, 2013 | Toshiba American Medical Systems Inc MRT-1504/A4 - Titan X MRI System
MRT-30 I0A/5 - Titan 3T MRI System
Product Usage: MRI System. Terminated |
LNH | K113093 K120638 |
| Apr 8, 2013 | Toshiba American Medical Systems Inc Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Terminated |
JAK | K122109 |
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