Ingenia Elition R5.7.1 SP4 MR Systems
FDA 510(k) clearance K232030 · decided 2023-08-02
Clearance details
- K-number
- K232030
- Device name
- Ingenia Elition R5.7.1 SP4 MR Systems
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-07
- Decision date
- 2023-08-02
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems Nederland B.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Mo recall (Z-1962-2026) | Philips North America | 2026-04-27 |