REGIUS MODEL 210

GUDID 04560141925557

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner
Primary Device ID04560141925557
NIH Device Record Key5b629e4e-80da-4329-89fc-17a6334ca8bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGIUS MODEL 210
Version Model NumberA1YD
Company DUNS692076161
Company NameKONICA MINOLTA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS104560141925557 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-09-19

Devices Manufactured by KONICA MINOLTA, INC.

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04560141949287 - P-652022-11-25
04560141949294 - P-752022-11-25

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