FDA 510(k)

exoplan

K-Number: K213302 · 2022-05-03

Decision Date2022-05-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

exoplan is the device name listed in this FDA 510(k) record. The listed applicant is Exocad GmbH. It received FDA 510(k) clearance on 2022-05-03 under 510(k) number K213302. 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 exoplan?

exoplan is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Exocad GmbH. The 510(k) number is K213302.

When did exoplan receive FDA 510(k) clearance?

exoplan received FDA 510(k) clearance on 2022-05-03, under 510(k) number K213302.

Who is the listed applicant for exoplan?

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

What is the FDA product code for exoplan?

The FDA product code for exoplan is LLZ.

Other records listing Exocad GmbH 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.

K193352AbutmentCAD K183458exoplan 2.3

Related Devices (Code: LLZ)

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.