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SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM — Medison Co., Ltd. (510(k) K063580)

SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM — Medison Co., Ltd. (510(k) K063580) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM; Applicant: Medison Co., Ltd.; Clearance track: 510(k).

Device nameSONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
ApplicantMedison Co., Ltd.
Clearance track510(k)
Submission numberK063580
DecisionSubstantially Equivalent
Decision date2006-12-14
Date received2006-11-30
Product codeIYN
Device class2
Medical specialtyRadiology
Applicant locationKR
SourceopenFDA device

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