PHAROS— 510(k) K250170
Substantially EquivalentBrightonix Imaging
FDA 510(k) clearance K250170 for PHAROS, Substantially Equivalent on 2025-08-15. Applicant: Brightonix Imaging. Device class: 2.
Clearance details
- Applicant
- Brightonix Imaging
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code KPS
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