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FDA 510(k)

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100

K-Number: K082543 · 2008-10-14

ApplicantSonocine, Inc.
Decision Date2008-10-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Sonocine, Inc.. It received FDA 510(k) clearance on 2008-10-14 under 510(k) number K082543. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100?

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 is a medical device that received FDA 510(k) clearance on 2008-10-14. The listed applicant is Sonocine, Inc.. The 510(k) number is K082543.

When did SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 receive FDA 510(k) clearance?

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 received FDA 510(k) clearance on 2008-10-14, under 510(k) number K082543.

Who is the listed applicant for SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100?

The FDA 510(k) record lists Sonocine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100?

The FDA product code for SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 is IYO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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