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FDA 510(k)

Second Opinion® Panoramic

K-Number: K250525 · 2025-11-14

ApplicantPearl, Inc.
Decision Date2025-11-14
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion® Panoramic is a medical device manufactured by Pearl, Inc.. It received FDA 510(k) clearance on 2025-11-14 under approval number K250525. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Second Opinion® Panoramic?

Second Opinion® Panoramic is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by Pearl, Inc.. The 510(k) number is K250525.

When was Second Opinion® Panoramic approved by the FDA?

Second Opinion® Panoramic received FDA 510(k) clearance on 2025-11-14, under approval number K250525.

What company makes Second Opinion® Panoramic?

Second Opinion® Panoramic is manufactured by Pearl, Inc..

What is the FDA product code for Second Opinion® Panoramic?

The FDA product code for Second Opinion® Panoramic is MYN.

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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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