PHAROS— 510(k) K250170

Substantially Equivalent

Brightonix Imaging

FDA 510(k) clearance K250170 for PHAROS, Substantially Equivalent on 2025-08-15. Applicant: Brightonix Imaging.

Clearance details

Applicant: Brightonix Imaging
Product code: Code KPS
Advisory panel: Radiology
Date received: 2025-01-21
Decision date: 2025-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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