Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
FDA 510(k) clearance K190461 · decided 2019-06-04
Clearance details
- K-number
- K190461
- Device name
- Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-26
- Decision date
- 2019-06-04
- Days to decision
- 98 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 Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model N recall (Z-1951-2026) | Philips North America | 2026-04-27 |