MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00

Transducer, Ultrasonic, Diagnostic

TOSHIBA MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Model Ssa-680a Xario Xg Diagnostic Ultrasound System, Version 1.00.

Pre-market Notification Details

Device IDK072918
510k NumberK072918
Device Name:MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
ContactPaul Biggins
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
Subsequent Product CodeIYN
Subsequent Product CodeIYO
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-10-15
Decision Date2007-10-29
Summary:summary

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