Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4— 510(k) K173079
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K173079 for Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4, Substantially Equivalent on 2018-04-04. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Best Noord-Brabant, NL
Recent devices under product code LNH
view allMore clearances from Philips Medical Systems Nederland B.V.
view all- K254205 — Zenition 30
- 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 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K173079
K-number listed on FDA's recall record- Z-1952-2026 — Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
- 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, K251808
- 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.
- Z-1788-2025 — Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
- Z-1789-2025 — Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Z-1790-2025 — Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
- Z-1791-2025 — Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- Z-0389-2024 — Achieva 1.5T
- Z-0390-2024 — Achieva 1.5T Conversion
- Z-0392-2024 — Ingenia 1.5T CX
- Z-0393-2024 — Intera 1.5T
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.