FDA.report

510(k) K243234

Device
Second Opinion® CS
Applicant
Pearl, Inc.
510(k) number
K243234
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-12
Date received
2024-10-10
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
William Birdsall
Address
2515 Benedict Canyon Dr. Beverly Hills CA US 90210 90210

FDA Registration Numbers

Source Documents

510(k) summary PDF

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