Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems— 510(k) K193215

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

2019-11-21

Decision date

2020-04-10

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Best Noord-Brabant, NL

• 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
• K261331 — I-Genius (100019400)2026-07-31

• 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-1951-2026 — Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.Class II·Ongoing·Philips North America·20260414
• Z-1953-2026 — Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.Class II·Ongoing·Philips North America·20260414
• 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-1956-2026 — Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808Class II·Ongoing·Philips North America·20260414
• Z-1960-2026 — Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.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-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-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-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-1206-2026 — Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1207-2026 — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1208-2026 — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1209-2026 — Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1210-2026 — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1211-2026 — Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-1212-2026 — Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.Class II·Ongoing·Philips North America·20251203
• Z-2200-2025 — Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;Class II·Ongoing·Philips North America·20250630
• Z-2201-2025 — Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;Class II·Ongoing·Philips North America·20250630
• Z-2204-2025 — Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;Class II·Ongoing·Philips North America·20250630
• Z-2205-2025 — Ingenia 1.5T S Model Number (REF): 781347;Class II·Ongoing·Philips North America·20250630

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193215.