Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3— 510(k) K163116

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

2016-11-07

Decision date

2017-01-06

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Best Noord-Brabant, 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-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-2417-2021 — Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377Class II·Completed·Philips North America Llc·20210811
• Z-2342-2021 — Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341Class II·Terminated·Philips North America Llc·20210730
• Z-2343-2021 — Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342Class II·Terminated·Philips North America Llc·20210730
• Z-0910-2019 — Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging SystemClass II·Terminated·Philips Medical Systems Nederlands·20181221
• Z-0918-2019 — Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging SystemClass II·Terminated·Philips Medical Systems Nederlands·20181221
• Z-0919-2019 — Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging SystemClass II·Terminated·Philips Medical Systems Nederlands·20181221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163116.