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FDA 510(k)

ASCEND Image Viewer

K-Number: K192372 · 2020-02-14

ApplicantAscend Hit
Decision Date2020-02-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASCEND Image Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Ascend Hit. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K192372. 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 ASCEND Image Viewer?

ASCEND Image Viewer is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Ascend Hit. The 510(k) number is K192372.

When did ASCEND Image Viewer receive FDA 510(k) clearance?

ASCEND Image Viewer received FDA 510(k) clearance on 2020-02-14, under 510(k) number K192372.

Who is the listed applicant for ASCEND Image Viewer?

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

What is the FDA product code for ASCEND Image Viewer?

The FDA product code for ASCEND Image Viewer 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, 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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