510(k) K250170
K250170 is an FDA 510(k) premarket notification submitted by Brightonix Imaging for the device "PHAROS". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2025
- Date Received
- January 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type