510(k) K043147 ยท LNH System, Nuclear Magnetic Resonance Imaging
ACHIEVA FAMILY
| Applicant | Philips Medical Systems North America Co., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 15, 2005 |
| Received | Nov 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T for PET, Model Number 781477. 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.