FDA 510(k)

IMAGE ONE

K-Number: K250716 · 2025-07-23

Decision Date2025-07-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMAGE ONE is the device name listed in this FDA 510(k) record. The listed applicant is Infomed Software, S.L.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K250716. 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 IMAGE ONE?

IMAGE ONE is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Infomed Software, S.L.. The 510(k) number is K250716.

When did IMAGE ONE receive FDA 510(k) clearance?

IMAGE ONE received FDA 510(k) clearance on 2025-07-23, under 510(k) number K250716.

Who is the listed applicant for IMAGE ONE?

The FDA 510(k) record lists Infomed Software, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGE ONE?

The FDA product code for IMAGE ONE 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.