Cleared Traditional

Second Opinion Periapical Radiolucency Contours

K242600 · Pearl, Inc. · Radiology
Apr 2025
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K242600 is an FDA 510(k) clearance for the Second Opinion Periapical Radiolucency Contours, 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 April 11, 2025, 224 days after receiving the submission on August 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K242600 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date April 11, 2025
Days to Decision 224 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