Ingenia Ambition S and Ingenia Ambition X
FDA 510(k) clearance K181479 · decided 2018-08-03
Clearance details
- K-number
- K181479
- Device name
- Ingenia Ambition S and Ingenia Ambition X
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-05
- Decision date
- 2018-08-03
- Days to decision
- 59 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 Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732 recall (Z-0975-2024) | Philips North America | 2024-02-02 |
| Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023* recall (Z-1795-2021) | Philips North America Llc | 2021-06-04 |
| Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. recall (Z-1796-2021) | Philips North America Llc | 2021-06-04 |
| Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System recall (Z-0920-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System recall (Z-0921-2019) | Philips Medical Systems Nederlands | 2019-02-22 |