510(k) K052078 ยท LNH System, Nuclear Magnetic Resonance Imaging
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
| Applicant | Philips Medical Systems Nederland B.V., Bothell WA, US |
| Decision | Substantially Equivalent, Sep 7, 2005 |
| Received | Aug 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052078
| 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 |
| Sep 18, 2026 | Philips North America Llc Achieva 3.0T;
Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Achieva XR;
Model Numbers (REF): 1. 781153, 2. 781253; Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Inte Open, Classified |
LNH | None listed |
| Dec 14, 2023 | Philips North America Llc Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device. Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Conversion Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Ingenia 1.5T CX Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Intera 1.5T Open, Classified |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Mar 20, 2015 | Philips Medical Systems, Inc. Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.