BBX-PET Scanner

System, Tomography, Computed, Emission

Prescient Imaging, LLC

The following data is part of a premarket notification filed by Prescient Imaging, Llc with the FDA for Bbx-pet Scanner.

Pre-market Notification Details

Device IDK210450
510k NumberK210450
Device Name:BBX-PET Scanner
ClassificationSystem, Tomography, Computed, Emission
Applicant Prescient Imaging, LLC 12569 Crenshaw Blvd Hawthorne,  CA  90250
ContactFarhad Daghighian
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-02-16
Decision Date2021-03-17

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