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Medical device manufacturer

Hitachi Medical Systems America Inc

Hitachi Medical Systems America Inc holds 100 FDA 510(k) clearances across 13 product codes. Median elapsed review time is 78 days. openFDA lists 45 recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
100
Product codes
13
Median review
78 days
Recall records
45

How does FDA spell Hitachi Medical Systems America Inc?

FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
Hitachi Medical Systems America Incdevice/recallnormalised
Hitachi Medical Systems America Incdevice/enforcementnormalised
Hitachi Medical Systems America, Inc.device/510knormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Hitachi Medical Systems America Inc file in?

13 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
LNHSystem, Nuclear Magnetic Resonance Imaging5491 days
MOSCoil, Magnetic Resonance, Specialty1850 days
JAKSystem, X-Ray, Tomography, Computed1286 days
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic530 days
IYOSystem, Imaging, Pulsed Echo, Ultrasonic2115 days
LNISystem, Nuclear Magnetic Resonance Spectroscopic227 days
DQAOximeter1100 days
IZISystem, X-Ray, Angiographic142 days
IZLSystem, X-Ray, Mobile181 days
JAASystem, X-Ray, Fluoroscopic, Image-Intensified172 days
KPSSystem, Tomography, Computed, Emission19 days
LLZSystem, Image Processing, Radiological168 days
MUHSystem, X-Ray, Extraoral Source, Digital113 days

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 Hitachi Medical Systems America Inc had a recall?

openFDA lists 45 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-1282-2021Class IITerminatedIYN

    Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

  • Z-1341-2020Class IITerminatedITX

    These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

  • Z-0271-2020Class IITerminatedJAK

    There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

  • Z-2839-2018Class IITerminatedJAK

    The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.

  • Z-2479-2018Class IITerminatedLNH

    The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.

Showing the 5 most recently initiated of 45.

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 Hitachi Medical Systems America Inc cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K163528HITACHI Supria Whole-body X-ray CT System Phase 3JAK77
K162079TRILLIUM Oval Head Coil 32MOS51
K161748SUPRIA w/guideShot OptionJAK54
K160152Trillium Oval V 5.1 MRI SystemLNH119
K153547ECHELON Oval V 5.1 MRI SystemLNH111
K150595SCENARIA Phase 3 Whole-body X-ray CT SystemJAK235
K150565Supria Whole-body X-ray CT SystemJAK208
K151015ECHELON Oval V 5.0 MRI SystemLNH104
K143537Sirius Starmobile tiaraIZL81
K142734TRILLIUM Oval MR SystemLNH160

Source: openFDA device/510k · retrieved

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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.