Soniceye Ultrasound Transducer

FDA 510(k) K113832 · Blacktoe Medical Iii, Inc.

Substantially Equivalent

510(k) numberK113832

Submission

Device name
Soniceye Ultrasound Transducer
Applicant
Blacktoe Medical Iii, Inc.
Beaverton, OR, US
Received
December 27, 2011
Decision date
March 6, 2012
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was Soniceye Ultrasound Transducer cleared by the FDA?

Soniceye Ultrasound Transducer (K113832) received a 510(k) decision of Substantially Equivalent on March 6, 2012, 70 days after the submission was received.

What is the product code of K113832?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.