Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System— 510(k) K251397

Clearance details

Applicant

Philips Medical Systems Nederland B.V.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2025-05-06

Decision date

2025-06-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Best, NL

• K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
• K262622 — Swoop® Portable MR Imaging® System2026-08-19
• K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
• K253808 — AIR Recon DL2026-08-13
• K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

• K254205 — Zenition 302026-08-07
• K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T2026-07-30
• K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
• K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
• K253614 — EchoNavigator R5.02026-03-17

Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1954-2026 — Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.Class II·Ongoing·Philips North America·20260414
• Z-1958-2026 — Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808Class II·Ongoing·Philips North America·20260414
• Z-1961-2026 — Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.Class II·Ongoing·Philips North America·20260414
• Z-1962-2026 — Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.Class II·Ongoing·Philips North America·20260414
• Z-1964-2026 — Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.Class II·Ongoing·Philips North America·20260414
• Z-1965-2026 — Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.Class II·Ongoing·Philips North America·20260414
• Z-1968-2026 — Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.Class II·Ongoing·Philips North America·20260414
• Z-1969-2026 — Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.Class II·Ongoing·Philips North America·20260414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251397.