Cleared Traditional

K210365 - Second Opinion (FDA 510(k) Clearance)

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

K210365 · Pearl, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
389d
Days
Class 2
Risk

K210365 is an FDA 510(k) clearance for the Second Opinion. 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 March 4, 2022 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K210365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date March 04, 2022
Days to Decision 389 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
282d slower than avg
Panel avg: 107d · This submission: 389d
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 Consultant

Boston Medtech Advisors
Zvi Ladin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MYN Analyzer, Medical Image

All 35
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K210365.
qXR-Detect
K251934 · Qure.Ai Technologies · Jan 2026
Diagnocat
K252934 · DGNCT, LLC · Jan 2026
DS Core Detect
K253009 · Dentsply Sirona, Inc. · Jan 2026
DTX Studio Assist
K252086 · Nobel Biocare C/O Medicim NV · Nov 2025
Second Opinion® Panoramic
K250525 · Pearl, Inc. · Nov 2025
SugarBug (1.x)
K250264 · Bench7, Inc. · Nov 2025