Ingenia 1.5T and Ingenia 1.5T S R5.2
FDA 510(k) clearance K153324 · decided 2016-03-22
Clearance details
- K-number
- K153324
- Device name
- Ingenia 1.5T and Ingenia 1.5T S R5.2
- Applicant
- Philips Medical Systems Nederlands B.V.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-18
- Decision date
- 2016-03-22
- Days to decision
- 125 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 |
|---|---|---|
| Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), pat recall (Z-0973-2024) | Philips North America | 2024-02-02 |
| Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System recall (Z-0916-2019) | Philips Medical Systems Nederlands | 2019-02-22 |