Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
FDA 510(k) clearance K251397 · decided 2025-06-04
Clearance details
- K-number
- K251397
- Device name
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-06
- Decision date
- 2025-06-04
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
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