MODIFICATION OF ACUSON V510B TRANSDUCER

K933663 · Acuson Corp. · ITX · Jan 21, 1994 · Radiology

Device Facts

Record IDK933663
Device NameMODIFICATION OF ACUSON V510B TRANSDUCER
ApplicantAcuson Corp.
Product CodeITX · Radiology
Decision DateJan 21, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1570
Device ClassClass 2

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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