Achieva +10 more— 510(k) K251808

Clearance details

Device name as filed

Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

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

2025-06-12

Decision date

2025-07-11

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-1959-2026 — Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.Class 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-1963-2026 — Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808Class II·Ongoing·Philips North America·20260414
• Z-1967-2026 — Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.Class II·Ongoing·Philips North America·20260414
• Z-1204-2026 — Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251808.