Cleared Traditional

Second Opinion? Pediatric

K243893 · Pearl, Inc. · Radiology
May 2025
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K243893 is an FDA 510(k) clearance for the Second Opinion? Pediatric, 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 May 5, 2025, 138 days after receiving the submission on December 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K243893 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2024
Decision Date May 05, 2025
Days to Decision 138 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