Second Opinion Periapical Radiolucency Contours— 510(k) K242600

Name: FDA 510(k) clearance K242600
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Pearl, Inc.

FDA 510(k) clearance K242600 for Second Opinion Periapical Radiolucency Contours, Substantially Equivalent on 2025-04-11. Applicant: Pearl, Inc.. Device class: 2.

Clearance details

Applicant: Pearl, Inc.
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2024-08-30
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.