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FDA 510(k)

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

K-Number: K190186 · 2019-03-28

ApplicantEdan Instruments, Inc.
Decision Date2019-03-28
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2019-03-28 under 510(k) number K190186. 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 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System?

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-03-28. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K190186.

When did Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-03-28, under 510(k) number K190186.

Who is the listed applicant for Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System?

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

What is the FDA product code for Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System?

The FDA product code for Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System 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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