Cleared Traditional

Second Opinion? Panoramic

K250525 · Pearl, Inc. · Radiology
Nov 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K250525 is an FDA 510(k) clearance for the Second Opinion? Panoramic, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Pearl, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on November 14, 2025, 266 days after receiving the submission on February 21, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K250525 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date November 14, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers