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FDA 510(k)

True 3D Viewer Software

K-Number: K170167 · 2017-03-03

ApplicantEchopixel, Inc.
Decision Date2017-03-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

True 3D Viewer Software is the device name listed in this FDA 510(k) record. The listed applicant is Echopixel, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K170167. 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 True 3D Viewer Software?

True 3D Viewer Software is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Echopixel, Inc.. The 510(k) number is K170167.

When did True 3D Viewer Software receive FDA 510(k) clearance?

True 3D Viewer Software received FDA 510(k) clearance on 2017-03-03, under 510(k) number K170167.

Who is the listed applicant for True 3D Viewer Software?

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

What is the FDA product code for True 3D Viewer Software?

The FDA product code for True 3D Viewer Software is LLZ.

Related Clinical Trials

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.

NCT07705425EPX-HTG for Structural Heart ProceduresNOT_YET_RECRUITING

Other records listing Echopixel, Inc. 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.

K201365True 3D ViewerK193149True 3D Viewer Software

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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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