Portable X-Ray System

GUDID 00817100020117

SR-130 + DR Portable X-Ray System (100kV/30mA).

KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital
Primary Device ID00817100020117
NIH Device Record Key885bea6f-a3e3-410b-b149-d3435e4c368f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable X-Ray System
Version Model NumberXR300
Company DUNS080269345
Company NameKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817100020117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, X-Ray, Mobile

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 Date2016-09-24

On-Brand Devices [Portable X-Ray System]

00817100020353Portable X-Ray System-R
00817100020124SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
00817100020117SR-130 + DR Portable X-Ray System (100kV/30mA).

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