FUJIFILM Medical Systems U.S.A. Inc. 74 09 000-1

GUDID 08055186670112

This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device ID08055186670112
NIH Device Record Key4de9cb97-072b-4853-9069-7d01f9764f1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUJIFILM Medical Systems U.S.A. Inc.
Version Model NumberPersona C
Catalog Number74 09 000-1
Company DUNS440069847
Company NameA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108055186670112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-28
Device Publish Date2021-09-20

On-Brand Devices [FUJIFILM Medical Systems U.S.A. Inc.]

08055186670327This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
08055186670310This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
08055186670143This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
08055186670136This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
08055186670129This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
08055186670112This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu

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