Atlas FDA

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

FDA 510(k) clearance K213516 · decided 2022-03-03

Clearance details

K-number
K213516
Device name
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2021-11-03
Decision date
2022-03-03
Days to decision
120 days
Clearance type
Abbreviated
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Best Noord-Brabant, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mo recall (Z-1963-2026)Philips North America2026-04-27
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. recall (Z-1969-2026)Philips North America2026-04-27
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and recall (Z-1213-2026)Philips North America2026-01-29
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1 recall (Z-1214-2026)Philips North America2026-01-29
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; recall (Z-2207-2025)Philips North America2025-07-30
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; recall (Z-2214-2025)Philips North America2025-07-30
Product Name: Upgrade to MR 7700; Model Number: 782130; recall (Z-1792-2025)Philips North America Llc2025-05-16
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; recall (Z-1805-2025)Philips North America Llc2025-05-16
Enterprise 1.5T, Model Number: 781145; recall (Z-1770-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
Intera 1.0T Omni/Stellar, Model Number: 781102; recall (Z-1772-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
Intera 1.5T Master/Nova, Model Number: 781106; recall (Z-1776-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
SmartPath to dStream for 1.5T, Model Number: 782146; recall (Z-1782-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
SmartPath to dStream for 3.0T, Model Number: 782145; recall (Z-1783-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, recall (Z-3193-2024)Philips North America Llc2024-09-20
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscop recall (Z-3194-2024)Philips North America Llc2024-09-20
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectrosco recall (Z-3195-2024)Philips North America Llc2024-09-20
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectro recall (Z-3196-2024)Philips North America Llc2024-09-20
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spec recall (Z-3197-2024)Philips North America Llc2024-09-20
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spec recall (Z-3198-2024)Philips North America Llc2024-09-20
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectr recall (Z-3199-2024)Philips North America Llc2024-09-20
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectr recall (Z-3200-2024)Philips North America Llc2024-09-20
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic i recall (Z-3201-2024)Philips North America Llc2024-09-20
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic im recall (Z-3202-2024)Philips North America Llc2024-09-20
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional i recall (Z-3203-2024)Philips North America Llc2024-09-20
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-secti recall (Z-3204-2024)Philips North America Llc2024-09-20
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional recall (Z-3205-2024)Philips North America Llc2024-09-20
Ingenia Elition S, Magnetic Resonance System. recall (Z-1570-2024)Philips North America Llc2024-04-17
Ingenia Elition X, Magnetic Resonance System. recall (Z-1571-2024)Philips North America Llc2024-04-17
MR 7700, Magnetic Resonance System. recall (Z-1588-2024)Philips North America Llc2024-04-17
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. recall (Z-0951-2024)Philips North America2024-02-01
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 7821 recall (Z-2395-2023)Philips North America2023-08-11
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 recall (Z-2396-2023)Philips North America2023-08-11
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 7821 recall (Z-2398-2023)Philips North America2023-08-11
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 recall (Z-2399-2023)Philips North America2023-08-11
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 recall (Z-0459-2023)Philips North America Llc2022-12-08
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 recall (Z-0460-2023)Philips North America Llc2022-12-08
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 recall (Z-0461-2023)Philips North America Llc2022-12-08
Philips MR 7700 System, Model Number 782120 recall (Z-0462-2023)Philips North America Llc2022-12-08
Philips Upgrade to MR 7700 System, Model Number 782130 recall (Z-0463-2023)Philips North America Llc2022-12-08