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FDA 510(k)

CAAS MR 4D Flow

K-Number: K162376 · 2016-12-08

Decision Date2016-12-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS MR 4D Flow is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162376. 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 CAAS MR 4D Flow?

CAAS MR 4D Flow is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K162376.

When did CAAS MR 4D Flow receive FDA 510(k) clearance?

CAAS MR 4D Flow received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162376.

Who is the listed applicant for CAAS MR 4D Flow?

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

What is the FDA product code for CAAS MR 4D Flow?

The FDA product code for CAAS MR 4D Flow is LLZ.

Other records listing Pie Medical Imaging BV as applicant

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.

View all 10 devices →

Related Devices (Code: LLZ)

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.

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.