FDA.report

510(k) K250525

Device
Second Opinion® Panoramic
Applicant
Pearl, Inc.
510(k) number
K250525
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-14
Date received
2025-02-21
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

Related Records

Applicant Contact

Contact
Ashley Brown
Address
2515 Benedict Canyon Dr. Beverly Hills CA US 90210 90210

FDA Registration Numbers

Source Documents

510(k) summary PDF

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