Ingenia 1.5T and Ingenia 1.5T S R5.2— 510(k) K153324
Substantially EquivalentPhilips Medical Systems Nederlands B.V.
FDA 510(k) clearance K153324 for Ingenia 1.5T and Ingenia 1.5T S R5.2, Substantially Equivalent on 2016-03-22. Applicant: Philips Medical Systems Nederlands B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederlands 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 Nederlands B.V.
view allAdverse 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 K153324
K-number listed on FDA's recall record- Z-0973-2024 — Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
- Z-2413-2021 — Ingenia 1.5T S-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 Model: 781347
- Z-0916-2019 — Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153324.
Data sourced from openFDA. This site is unofficial and independent of the FDA.