FDA 510(k)

Ambra ProViewer

K-Number: K202335 · 2020-09-04

ApplicantDicom Grid Inc Dba Ambra Health

Decision Date2020-09-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ambra ProViewer is the device name listed in this FDA 510(k) record. The listed applicant is Dicom Grid Inc Dba Ambra Health. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K202335. 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 Ambra ProViewer?

Ambra ProViewer is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Dicom Grid Inc Dba Ambra Health. The 510(k) number is K202335.

When did Ambra ProViewer receive FDA 510(k) clearance?

Ambra ProViewer received FDA 510(k) clearance on 2020-09-04, under 510(k) number K202335.

Who is the listed applicant for Ambra ProViewer?

The FDA 510(k) record lists Dicom Grid Inc Dba Ambra Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambra ProViewer?

The FDA product code for Ambra ProViewer 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

View on FDA Database →

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