ADC QS/IPD WORKSTATION

System, Image Processing, Radiological

AGFA CORP.

The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Adc Qs/ipd Workstation.

Pre-market Notification Details

Device IDK010571
510k NumberK010571
Device Name:ADC QS/IPD WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville,  MD  20852
ContactT. Whit Athey
CorrespondentT. Whit Athey
AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville,  MD  20852
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-26
Decision Date2001-03-28

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