ClearanceBrief
510(k) K213516 ยท LNH System, Nuclear Magnetic Resonance Imaging

Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Mar 3, 2022
ReceivedNov 3, 2021
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K213516

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Philips North America
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10.
Open, Classified
LNHNone listed
Sep 25, 2026Philips North America
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Open, Classified
LNHNone listed
Sep 25, 2026Philips North America
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Open, Classified
LNHNone listed
Sep 18, 2026Philips North America Llc
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
Open, Classified
LNHNone listed
Sep 18, 2026Philips North America Llc
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Open, Classified
LNHNone listed
Sep 18, 2026Philips North America Llc
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (
Open, Classified
LNHNone listed
Apr 27, 2026Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972,
Open, Classified
LNHNone listed
Apr 27, 2026Philips North America
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Open, Classified
LNHNone listed
Jan 29, 2026Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Open, Classified
LNHNone listed
Jan 29, 2026Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Open, Classified
LNHNone listed
Jul 30, 2025Philips North America
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Open, Classified
LNHNone listed
Jul 30, 2025Philips North America
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
Open, Classified
LNHNone listed
May 16, 2025Philips North America Llc
Product Name: Upgrade to MR 7700; Model Number: 782130;
Open, Classified
LNHNone listed
May 16, 2025Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Open, Classified
LNHNone listed
May 15, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Enterprise 1.5T, Model Number: 781145;
Open, Classified
LNHNone listed
May 15, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.0T Omni/Stellar, Model Number: 781102;
Open, Classified
LNHNone listed
May 15, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Master/Nova, Model Number: 781106;
Open, Classified
LNHNone listed
May 15, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 1.5T, Model Number: 782146;
Open, Classified
LNHNone listed
May 15, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 3.0T, Model Number: 782145;
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
Apr 17, 2024Philips North America Llc
Ingenia Elition S, Magnetic Resonance System.
Open, Classified
LNHNone listed
Apr 17, 2024Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Open, Classified
LNHNone listed
Apr 17, 2024Philips North America Llc
MR 7700, Magnetic Resonance System.
Open, Classified
LNHNone listed
Feb 1, 2024Philips North America
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Open, Classified
LNINone listed
Aug 11, 2023Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Open, Classified
LNHNone listed
Aug 11, 2023Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Open, Classified
LNHNone listed
Aug 11, 2023Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Open, Classified
LNHNone listed
Aug 11, 2023Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Open, Classified
LNHNone listed
Dec 8, 2022Philips North America Llc
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Open, Classified
LNHNone listed
Dec 8, 2022Philips North America Llc
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Open, Classified
LNHNone listed
Dec 8, 2022Philips North America Llc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Open, Classified
LNHNone listed
Dec 8, 2022Philips North America Llc
Philips MR 7700 System, Model Number 782120
Open, Classified
LNHNone listed
Dec 8, 2022Philips North America Llc
Philips Upgrade to MR 7700 System, Model Number 782130
Open, Classified
LNHNone listed

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