Cleared Traditional

Second Opinion? CS

K243234 · Pearl, Inc. · Radiology
Jun 2025
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K243234 is an FDA 510(k) clearance for the Second Opinion? CS, 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 June 12, 2025, 245 days after receiving the submission on October 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K243234 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2024
Decision Date June 12, 2025
Days to Decision 245 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