Nucleus.io

System, Image Processing, Radiological

NucleusHealth, LLC

The following data is part of a premarket notification filed by Nucleushealth, Llc with the FDA for Nucleus.io.

Pre-market Notification Details

Device IDK203249
510k NumberK203249
Device Name:Nucleus.io
ClassificationSystem, Image Processing, Radiological
Applicant NucleusHealth, LLC 13280 Evening Creek Dr. Ste 110 San Diego,  CA  92128
ContactZachary Wright
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-11-04
Decision Date2020-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17540262160017 K203249 000
17540262160109 K203249 000
17540262160093 K203249 000
17540262160086 K203249 000
17540262160079 K203249 000
17540262160062 K203249 000
17540262160048 K203249 000
17540262160055 K203249 000
17540262160031 K203249 000
17540262160024 K203249 000
17540262140026 K203249 000
17540262160116 K203249 000

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