ClearanceBrief
510(k) K212673 ยท LNH System, Nuclear Magnetic Resonance Imaging

MR 5300

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Nov 19, 2021
ReceivedAug 24, 2021
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K212673

DateFirm and productCodeLinked 510(k)
Jul 30, 2025Philips North America
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Open, Classified
LNHNone listed
May 16, 2025Philips North America Llc
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orienta
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (RE
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) N
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Nu
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities,
Open, Classified
LNHNone listed
Sep 20, 2024Philips North America Llc
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any
Open, Classified
LNHNone listed
May 17, 2024Philips North America Llc
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
Open, Classified
LNHNone listed
Apr 17, 2024Philips North America Llc
MR 5300, Magnetic Resonance System.
Open, Classified
LNHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.