S12 Digital Color Doppler Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

SONOSCAPE MEDICAL CORP.

The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for S12 Digital Color Doppler Ultrasound System.

Pre-market Notification Details

Device IDK152396
510k NumberK152396
Device Name:S12 Digital Color Doppler Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSCAPE MEDICAL CORP. 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, Nanshan Shenzhen,  CN 518051
ContactToki Wu
CorrespondentToki Wu
SONOSCAPE MEDICAL CORP. 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, Nanshan Shenzhen,  CN 518051
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-24
Decision Date2015-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945868611217 K152396 000
06945868611200 K152396 000

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