510(k) K253648
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades by
Philips Medical Systems Nederland B.V.
— Product Code LNH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2026
- Date Received
- November 20, 2025
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type