QT Scanner 2000 Model A

System, Imaging, Pulsed Echo, Ultrasonic

QT Imaging, Inc.

The following data is part of a premarket notification filed by Qt Imaging, Inc. with the FDA for Qt Scanner 2000 Model A.

Pre-market Notification Details

Device IDK220933
510k NumberK220933
Device Name:QT Scanner 2000 Model A
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant QT Imaging, Inc. 3 Hamilton Landing, Suite 160 Novato,  CA  94949
ContactJohn Klock
CorrespondentJohn Klock
QT Imaging, Inc. 3 Hamilton Landing, Suite 160 Novato,  CA  94949
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-08-31

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