FDA 510(k)

WebPAX

K-Number: K152949 · 2016-08-17

ApplicantHeart Imaging Technologies, LLC

Decision Date2016-08-17

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WebPAX is the device name listed in this FDA 510(k) record. The listed applicant is Heart Imaging Technologies, LLC. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K152949. 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 WebPAX?

WebPAX is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Heart Imaging Technologies, LLC. The 510(k) number is K152949.

When did WebPAX receive FDA 510(k) clearance?

WebPAX received FDA 510(k) clearance on 2016-08-17, under 510(k) number K152949.

Who is the listed applicant for WebPAX?

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

What is the FDA product code for WebPAX?

The FDA product code for WebPAX is LLZ.

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.