510(k) K030520 ยท LNH System, Nuclear Magnetic Resonance Imaging
INTERA FAMILY
| Applicant | Philips Medical Systems North America Co., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 6, 2003 |
| Received | Feb 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Intera 0.5T Standard, Model 781101
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the intern Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any Terminated |
LNH | None listed |
| Feb 26, 2016 | Philips Electronics North America Corporation SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.