FDA 510(k)

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS

K-Number: K041675 · 2004-07-23

Decision Date2004-07-23

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K041675. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS?

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Pie Medical. The 510(k) number is K041675.

When did PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS receive FDA 510(k) clearance?

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041675.

Who is the listed applicant for PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS?

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

What is the FDA product code for PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS?

The FDA product code for PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS is IYN.

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Other records listing Pie Medical as applicant

K061961ART LAB SOFTWARE K053154MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM K043588MYLAB 15 / MYLAB 20, MODEL 2700 K043360IMT.LAB K033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L K023512PICUS ULTRASOUND IMAGING SYSTEMS

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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.