Company ยท NL
Philips Medical Systems Nederlands
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2024. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
83recalls (0 in 12 months)
70recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 70 |
| OWB | Interventional Fluoroscopic X-Ray System | 6 |
| IZI | System, X-Ray, Angiographic | 5 |
| KPR | System, X-Ray, Stationary | 5 |
| IXR | Table, Radiographic, Tilting | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2024 | K240224 | Zenition 90 Philips Medical Systems Nederlands B.V., NL | OWB |
| Dec 23, 2022 | K223442 | MR 5300 and MR 7700 R11 MR Systems Philips Medical Systems Nederlands B.V., NL | LNH |
| Feb 23, 2021 | K201743 | ClarifEye R1.0, ClarifEye Needle Philips Medical Systems Nederlands B.V., NL | OWB |
| Sep 7, 2018 | K181311 | Philips Hemodynamic Application R1.0 Philips Medical Systems Nederlands B.V., NL | MWI |
| Aug 17, 2018 | K181966 | SmartPerfusion Philips Medical Systems Nederlands B.V., NL | OWB |
| Oct 18, 2016 | K162025 | IntelliSpace Portal Platform Philips Medical Systems Nederlands B.V., NL | LLZ |
| Mar 22, 2016 | K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 Philips Medical Systems Nederlands B.V., NL | LNH |
| Mar 20, 2015 | K143128 | mDIXON XD Philips Medical Systems Nederlands B.V., NL | LNH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2019 | Philips Medical Systems Nederlands Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED),
Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply p Terminated |
LNH | K181479 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K110151 |
| Feb 22, 2019 | Philips Medical Systems Nederlands MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K110151 |
| Feb 22, 2019 | Philips Medical Systems Nederlands MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K110151 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K173356 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K173356 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K181479 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K181479 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K163116 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K163116 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K041602 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K153324 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K163116 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K162931 |
| Feb 22, 2019 | Philips Medical Systems Nederlands SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K162931 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K162931 |
| Feb 22, 2019 | Philips Medical Systems Nederlands SmartPath to dStream for 1.5T, Model Number 781260. 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 | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K041602 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K013344 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
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