Skip to content

Medical device manufacturer

Toshiba America Medical Systems, In.C

Toshiba America Medical Systems, In.C holds 146 FDA 510(k) clearances across 30 product codes. Median elapsed review time is 45 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
146
Product codes
30
Median review
45 days
Recall records
0

How does FDA spell Toshiba America Medical Systems, In.C?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Toshiba America Medical Systems, In.C file in?

30 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
JAKSystem, X-Ray, Tomography, Computed3535 days
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2215 days
JAASystem, X-Ray, Fluoroscopic, Image-Intensified1349 days
LLZSystem, Image Processing, Radiological1033 days
LNHSystem, Nuclear Magnetic Resonance Imaging1015 days
ITXTransducer, Ultrasonic, Diagnostic957 days
IYOSystem, Imaging, Pulsed Echo, Ultrasonic915 days
KPSSystem, Tomography, Computed, Emission677 days
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)514 days
OWBInterventional Fluoroscopic X-Ray System315 days
IZISystem, X-Ray, Angiographic277 days
IZOGenerator, High-Voltage, X-Ray, Diagnostic240 days
IZZTable, Radiographic, Non-Tilting, Powered215 days
MOSCoil, Magnetic Resonance, Specialty28 days
DXKEchocardiograph187 days
DXTInjector And Syringe, Angiographic176 days
GXWEchoencephalograph185 days
IXRTable, Radiographic, Tilting1108 days
IYDGenerator, Low Voltage, Therapeutic X-Ray1470 days
IYXCamera, Scintillation (Gamma)1112 days
JWMSystem, Tomographic, Nuclear184 days
KPQSystem, Simulation, Radiation Therapy1330 days
KPRSystem, X-Ray, Stationary179 days
KPWDevice, Beam Limiting, X-Ray, Diagnostic186 days
KXJTable, Radiologic182 days

Showing the 25 they file in most, of 30.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Toshiba America Medical Systems, In.C had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Toshiba America Medical Systems, In.C cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K141472VANTAGE ELANLNH108
K133553KALAREJAA206
K140729APLIO ARTIDA, V3.2IYN60
K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREJAA127
K131822ULTRAEXTEND USWS-900A V2.1 AND V3.1LLZ33
K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801JAA134
K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USLNH108
K122842RADREX-I, SW V4.00 MODEL DRAD-3000EMQB22
K121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGELLZ183
K122109AQUILION ONE VISION, V4.90JAK66

Source: openFDA device/510k · retrieved

Watch what Toshiba America Medical Systems, In.C files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.