CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE

System, Imaging, Pulsed Doppler, Ultrasonic

CHISON MEDICAL IMAGING CO., LTD.

The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe.

Pre-market Notification Details

Device IDK131305
510k NumberK131305
Device Name:CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin,  CA  94568
ContactBob Leiker
CorrespondentBob Leiker
CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin,  CA  94568
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-07
Decision Date2013-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945121409698 K131305 000
B369MUS05185 K131305 000
B369MUS05184 K131305 000
B369MUS05183 K131305 000
B369MUS05182 K131305 000
B369MUS05181 K131305 000
B369MUS05179 K131305 000
B369MUS05178 K131305 000
B369MUS05177 K131305 000
B369MUS01027 K131305 000
06945121407915 K131305 000
06945121407991 K131305 000
06945121407502 K131305 000
06945121407496 K131305 000
06945121407489 K131305 000
06945121407472 K131305 000
06945121407465 K131305 000
06945121407458 K131305 000
06945121407441 K131305 000
06945121408158 K131305 000
06945121408073 K131305 000
B369MUS01026 K131305 000

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