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FDA 510(k)

IMAGE ONE

K-Number: K250716 · 2025-07-23

ApplicantInfomed Software, S.L.
Decision Date2025-07-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE ONE is a medical device manufactured by Infomed Software, S.L.. It received FDA 510(k) clearance on 2025-07-23 under approval 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. It is manufactured by Infomed Software, S.L.. The 510(k) number is K250716.

When was IMAGE ONE approved by the FDA?

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

What company makes IMAGE ONE?

IMAGE ONE is manufactured by Infomed Software, S.L..

What is the FDA product code for IMAGE ONE?

The FDA product code for IMAGE ONE is LLZ.

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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.

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