510(k) K052013 ยท LNH System, Nuclear Magnetic Resonance Imaging
ACHIEVA 1.5T & INERA 1.5T FAMILY
| Applicant | Philips Medical Systems Nederland B.V., Bothell WA, US |
| Decision | Substantially Equivalent, Aug 2, 2005 |
| Received | Jul 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052013
| 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 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 |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits Open, Classified |
MOS | None listed |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 45 Open, Classified |
MOS | None listed |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 45356750228 Open, Classified |
MOS | 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 Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4)
Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explore Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) A Terminated |
LNH | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.