510(k) K063559 ยท LNH System, Nuclear Magnetic Resonance Imaging
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Jan 4, 2007 |
| Received | Nov 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063559
| 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 |
| May 17, 2024 | Philips North America Llc Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781350 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 |
| Nov 23, 2015 | Philips Medical Systems, Inc. Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Terminated |
LNH | None listed |
| May 5, 2014 | Philips Medical Systems, Inc. All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic Terminated |
LNH | None listed |
| Feb 6, 2009 | Invivo Corporation 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826
These rechargeab Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.