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510(k) K243614

Device
Sonio Suspect
Applicant
Sonio
510(k) number
K243614
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-21
Date received
2024-11-22
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Florian Akpakpa
Address
17 Rue Du Faubourg Montmartre Paris FR 75009 75009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K221564Brainomix 360 e-ASPECTSBrainomix Limited2023-02-23
K221624Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc.2022-11-22
K212616Koios DSKoios Medical, Inc.2021-12-16