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 Xd.

Pre-market Notification Details

Device IDK220779
510k NumberK220779
Device Name:XD
ClassificationSystem, Image Processing, Radiological
Applicant Mirada Medical Ltd New Barclay House, 234 Botley Road Oxford,  GB Ox2 0hp
ContactAdam Taylor
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-03-17
Decision Date2022-04-15


Device IdentifiersubmissionNumberSupplement
B334XD4P00 K220779 000

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