InnoSight Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Qisda Corporation

The following data is part of a premarket notification filed by Qisda Corporation with the FDA for Innosight Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK192254
510k NumberK192254
Device Name:InnoSight Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Qisda Corporation No.157, Shanying Rd, Shan-Ting Li, Gueishan Dist, Taoyuan,  TW
ContactJohnson Sheu
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-08-20
Decision Date2019-09-18
Summary:summary

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