Cleared Traditional

K243893 - Second Opinion® Pediatric (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K243893 is an FDA 510(k) clearance for the Second Opinion® Pediatric. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Pearl, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on May 5, 2025 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pearl, Inc. devices

Submission Details

510(k) Number K243893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 107d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MYN Analyzer, Medical Image

All 35
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