System, Image Processing, Radiological

EXINI Diagnostics AB

The following data is part of a premarket notification filed by Exini Diagnostics Ab with the FDA for Apromise X.

Pre-market Notification Details

Device IDK220590
510k NumberK220590
Device Name:APROMISE X
ClassificationSystem, Image Processing, Radiological
Applicant EXINI Diagnostics AB Ideon Science Park, Scheelevagen 27 Lund,  SE Se-223 70
ContactAseem Anand
CorrespondentDonna-bea Tillman
Biologics Consulting Group 1555 King Street Alexandria,  VA  22314
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-04-29

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