ClearanceBrief
510(k) K163116 ยท LNH System, Nuclear Magnetic Resonance Imaging

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Jan 6, 2017
ReceivedNov 7, 2016
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K163116

DateFirm and productCodeLinked 510(k)
Apr 27, 2026Philips North America
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K
Open, Classified		 LNHNone listed
Aug 11, 2021Philips North America Llc
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orienta
Completed		 LNHNone listed
Jul 30, 2021Philips North America Llc
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientati
Terminated		 LNHNone listed
Jul 30, 2021Philips North America Llc
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientati
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed

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