Atlas FDA

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

FDA 510(k) clearance K183063 · decided 2019-02-14

Clearance details

K-number
K183063
Device name
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2018-11-05
Decision date
2019-02-14
Days to decision
101 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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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model N recall (Z-1956-2026)Philips North America2026-04-27
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. recall (Z-1957-2026)Philips North America2026-04-27
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7 recall (Z-1965-2026)Philips North America2026-04-27
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW versi recall (Z-1216-2026)Philips North America2026-01-29
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 78 recall (Z-1788-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 recall (Z-1789-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; recall (Z-1790-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; recall (Z-1791-2025)Philips North America Llc2025-05-16
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732 recall (Z-0975-2024)Philips North America2024-02-02
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