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FDA 510(k)

R4 ACERT ULTRASOUND REPORTING SYSTEM

K-Number: K101898 · 2011-09-15

ApplicantR4, LLC
Decision Date2011-09-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R4 ACERT ULTRASOUND REPORTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is R4, LLC. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K101898. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R4 ACERT ULTRASOUND REPORTING SYSTEM?

R4 ACERT ULTRASOUND REPORTING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is R4, LLC. The 510(k) number is K101898.

When did R4 ACERT ULTRASOUND REPORTING SYSTEM receive FDA 510(k) clearance?

R4 ACERT ULTRASOUND REPORTING SYSTEM received FDA 510(k) clearance on 2011-09-15, under 510(k) number K101898.

Who is the listed applicant for R4 ACERT ULTRASOUND REPORTING SYSTEM?

The FDA 510(k) record lists R4, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R4 ACERT ULTRASOUND REPORTING SYSTEM?

The FDA product code for R4 ACERT ULTRASOUND REPORTING SYSTEM is LLZ.

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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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