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FDA 510(k)

Aixplorer

K-Number: K161999 · 2016-11-16

Decision Date2016-11-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aixplorer is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K161999. 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 Aixplorer?

Aixplorer is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Supersonic Imagine. The 510(k) number is K161999.

When did Aixplorer receive FDA 510(k) clearance?

Aixplorer received FDA 510(k) clearance on 2016-11-16, under 510(k) number K161999.

Who is the listed applicant for Aixplorer?

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

What is the FDA product code for Aixplorer?

The FDA product code for Aixplorer is IYN.

Other records listing Supersonic Imagine 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 9 devices →

Related Devices (Code: IYN)

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

View on FDA Database →

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