Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
FDA 510(k) clearance K253648 · decided 2026-02-23
Clearance details
- K-number
- K253648
- Device name
- Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-20
- Decision date
- 2026-02-23
- Days to decision
- 95 days
- Clearance type
- Abbreviated
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| I-Genius (100019400) (K261331) | Esaote, S.p.A. | 2026-07-31 |
| MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (K260852) | Siemens Healthineers AG | 2026-07-31 |
| uMR Astra (K260113) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| APERTO Lucent MRI System (K253862) | Fujifilm Corporation | 2026-04-06 |
| S-scan Open (100001800) (K260746) | Esaote, S.p.A. | 2026-03-27 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) | Canon Medical Systems Corporation | 2026-03-27 |
| nordicAudio (1.0) (K251937) | Nordicneurolab AS | 2026-03-20 |
| Embrace Neonatal MRI System (K254277) | Aspect Imaging, Ltd. | 2026-03-13 |
| LiverMultiScan (v6.0) (K253413) | Perspectum, Ltd. | 2026-03-09 |
| Magnifico Open (100009900) (K251901) | Esaote, S.p.A. | 2026-03-05 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K260265) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| SIGNA™ Bolt (K253780) | Ge Medical Systems, LLC | 2026-02-06 |
Recalls involving this device
No recalls on record reference this clearance.