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FDA 510(k)

UltraScan 650

K-Number: K161919 · 2017-04-05

ApplicantCyberlogic, Inc.
Decision Date2017-04-05
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UltraScan 650 is the device name listed in this FDA 510(k) record. The listed applicant is Cyberlogic, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K161919. The device is classified under product code MUA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraScan 650?

UltraScan 650 is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Cyberlogic, Inc.. The 510(k) number is K161919.

When did UltraScan 650 receive FDA 510(k) clearance?

UltraScan 650 received FDA 510(k) clearance on 2017-04-05, under 510(k) number K161919.

Who is the listed applicant for UltraScan 650?

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

What is the FDA product code for UltraScan 650?

The FDA product code for UltraScan 650 is MUA.

Related Devices (Code: MUA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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