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FDA 510(k)

RadioLens v1.0

K-Number: K222174 · 2023-03-28

ApplicantSynapsica
Decision Date2023-03-28
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadioLens v1.0 is a medical device manufactured by Synapsica. It received FDA 510(k) clearance on 2023-03-28 under approval number K222174. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadioLens v1.0?

RadioLens v1.0 is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Synapsica. The 510(k) number is K222174.

When was RadioLens v1.0 approved by the FDA?

RadioLens v1.0 received FDA 510(k) clearance on 2023-03-28, under approval number K222174.

What company makes RadioLens v1.0?

RadioLens v1.0 is manufactured by Synapsica.

What is the FDA product code for RadioLens v1.0?

The FDA product code for RadioLens v1.0 is QIH.

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Official Source

View on FDA Database →

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