Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
FDA 510(k) clearance K163116 · decided 2017-01-06
Clearance details
- K-number
- K163116
- Device name
- Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-07
- Decision date
- 2017-01-06
- Days to decision
- 60 days
- Clearance type
- Abbreviated
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model N recall (Z-1956-2026) | Philips North America | 2026-04-27 |
| Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System recall (Z-0910-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System recall (Z-0918-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System recall (Z-0919-2019) | Philips Medical Systems Nederlands | 2019-02-22 |