RADspeed Pro

GUDID 04540217071319

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital
Primary Device ID04540217071319
NIH Device Record Keybdebb2ca-4670-4552-b578-d0d2c16b3946
Commercial Distribution StatusIn Commercial Distribution
Brand NameRADspeed Pro
Version Model Number566-26000-50
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
GS104540217071319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

On-Brand Devices [RADspeed Pro]

04540217059959503-79460-52
04540217059942503-79460-51
04540217052493503-79460-43
04540217052486503-79460-42
04540217052479503-79460-41
04540217052424503-79460-26
04540217052417503-79460-23
04540217052400503-79460-22
04540217052394503-79460-21
04540217052387503-79460-06
04540217052370503-79460-03
04540217052363503-79460-02
04540217052356503-79460-01
04540217040315503-77550-11
04540217040308503-77550-10
04540217040292503-77550-09
04540217060269503-79460-64
04540217060252503-79460-63
04540217060245503-79460-62
04540217060238503-79460-61
04540217060221503-79460-53
04540217071395566-26000-65
04540217071388566-26000-64
04540217071371566-26000-63
04540217071364566-26000-62
04540217071357566-26000-61
04540217071340566-26000-60
04540217071333566-26000-54
04540217071326566-26000-53
04540217071319566-26000-50

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