17X17 GOS Fixed Flat Panel Detector

GUDID 00817100020223

IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)

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

Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system
Primary Device ID00817100020223
NIH Device Record Keyfe7f7f17-cfeb-4a19-9ea1-a2101a58316b
Commercial Distribution StatusIn Commercial Distribution
Brand Name17X17 GOS Fixed Flat Panel Detector
Version Model NumberPAN221
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

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817100020223 [Primary]

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 Number3
Public Version Date2019-02-21
Device Publish Date2016-09-24

Devices Manufactured by KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

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