FDA.report

510(k) K242522

Device
Second Opinion CC
Applicant
Pearl, Inc.
510(k) number
K242522
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-16
Date received
2024-08-23
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
William Birdsall
Address
2515 Benedict Canyon Dr. Beverly Hills CA US 90210 90210

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K251002Videa Dental AIVideahealth, Inc.2025-09-19
K250753VELMENI for DENTISTS (V4D)Velmeni, Inc.2025-09-02
K243234Second Opinion® CSPearl, Inc.2025-06-12
K242437Smile Dx®Cube Click, Inc.2025-05-14
K243893Second Opinion® PediatricPearl, Inc.2025-05-05
K243239Lung AI (LAI001)Exo, Inc.2025-04-24
K242600Second Opinion Periapical Radiolucency ContoursPearl, Inc.2025-04-11
K243831Rayvolve LNAZmed2025-03-26