Aline Ablation Intelligence

System, Image Processing, Radiological

Mirada Medical Ltd

The following data is part of a premarket notification filed by Mirada Medical Ltd with the FDA for Aline Ablation Intelligence.

Pre-market Notification Details

Device IDK202297
510k NumberK202297
Device Name:Aline Ablation Intelligence
ClassificationSystem, Image Processing, Radiological
Applicant Mirada Medical Ltd New Barclay House, 234 Botley Road Oxford,  GB Ox2 0hp
ContactDavid Clafton
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-13
Decision Date2020-09-11

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