510(k) K190461 ยท LNH System, Nuclear Magnetic Resonance Imaging
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Jun 4, 2019 |
| Received | Feb 26, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K190461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Philips North America Llc Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system;
Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Achieva 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781196.
2. Model Number (REF): 781296. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.