Atlas FDA

MR 5300

FDA 510(k) clearance K212673 · decided 2021-11-19

Clearance details

K-number
K212673
Device name
MR 5300
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2021-08-24
Decision date
2021-11-19
Days to decision
87 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
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; recall (Z-2213-2025)Philips North America2025-07-30
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; recall (Z-1804-2025)Philips North America Llc2025-05-16
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
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use recall (Z-1854-2024)Philips North America Llc2024-05-17
MR 5300, Magnetic Resonance System. recall (Z-1587-2024)Philips North America Llc2024-04-17