FDA 510(k)

UniCam Evo Software

K-Number: K230393 · 2023-04-13

ApplicantInter Medical Medizintechnik GmbH

Decision Date2023-04-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UniCam Evo Software is the device name listed in this FDA 510(k) record. The listed applicant is Inter Medical Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230393. 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 UniCam Evo Software?

UniCam Evo Software is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Inter Medical Medizintechnik GmbH. The 510(k) number is K230393.

When did UniCam Evo Software receive FDA 510(k) clearance?

UniCam Evo Software received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230393.

Who is the listed applicant for UniCam Evo Software?

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

What is the FDA product code for UniCam Evo Software?

The FDA product code for UniCam Evo Software 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.