IA-16LT/HS

GUDID 04540217020195

SHIMADZU CORPORATION

X-ray image intensifier
Primary Device ID04540217020195
NIH Device Record Key411c908a-5e6c-40fc-b3f4-e59cdd30d230
Commercial Distribution StatusIn Commercial Distribution
Brand NameIA-16LT/HS
Version Model Number532-16727-01
Company DUNS690558747
Company NameSHIMADZU CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104540217020195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by SHIMADZU CORPORATION

04540217071319 - RADspeed Pro2024-04-09
04540217071326 - RADspeed Pro2024-04-09
04540217071333 - RADspeed Pro2024-04-09
04540217071340 - RADspeed Pro2024-04-09
04540217071357 - RADspeed Pro2024-04-09
04540217071364 - RADspeed Pro2024-04-09
04540217071371 - RADspeed Pro2024-04-09
04540217071388 - RADspeed Pro2024-04-09

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