510(k) K223442 ยท LNH System, Nuclear Magnetic Resonance Imaging
MR 5300 and MR 7700 R11 MR Systems
| Applicant | Philips Medical Systems Nederlands B.V., Best, NL |
| Decision | Substantially Equivalent, Dec 23, 2022 |
| Received | Nov 14, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Philips North America MR 5300;
Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc MR 5300
Model Number (REF): 1. 782110, 2. 782152; Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America Upgrade to MR 7700.
Product Code (REF): 782130.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America MR 5300
Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: MR 5300;
Model Numbers: (1) 782110, (2) 782152; Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.