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FDA 510(k)

Second Opinion® 3D

K-Number: K243989 · 2025-05-23

ApplicantPearl, Inc.
Decision Date2025-05-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion® 3D is a medical device manufactured by Pearl, Inc.. It received FDA 510(k) clearance on 2025-05-23 under approval number K243989. 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 Second Opinion® 3D?

Second Opinion® 3D is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Pearl, Inc.. The 510(k) number is K243989.

When was Second Opinion® 3D approved by the FDA?

Second Opinion® 3D received FDA 510(k) clearance on 2025-05-23, under approval number K243989.

What company makes Second Opinion® 3D?

Second Opinion® 3D is manufactured by Pearl, Inc..

What is the FDA product code for Second Opinion® 3D?

The FDA product code for Second Opinion® 3D is QIH.

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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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