Atlas FDA

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

FDA 510(k) clearance K213583 · decided 2022-05-16

Clearance details

K-number
K213583
Device name
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2021-11-12
Decision date
2022-05-16
Days to decision
185 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 Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2 recall (Z-1954-2026)Philips North America2026-04-27
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. recall (Z-1955-2026)Philips North America2026-04-27
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 Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. M recall (Z-1960-2026)Philips North America2026-04-27
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. M recall (Z-1961-2026)Philips North America2026-04-27
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7 recall (Z-1966-2026)Philips North America2026-04-27
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number ( recall (Z-1967-2026)Philips North America2026-04-27
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): recall (Z-1968-2026)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
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW ve recall (Z-1204-2026)Philips North America2026-01-29
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R recall (Z-1205-2026)Philips North America2026-01-29
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with recall (Z-1210-2026)Philips North America2026-01-29
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11. recall (Z-1215-2026)Philips North America2026-01-29
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 7821 recall (Z-2204-2025)Philips North America2025-07-30
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), ( recall (Z-2208-2025)Philips North America2025-07-30
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; recall (Z-2209-2025)Philips North America2025-07-30
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, recall (Z-1795-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; recall (Z-1798-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; recall (Z-1801-2025)Philips North America Llc2025-05-16
HA FlexTrak-Patient transport functionality to transport the patient from the preparation recall (Z-1948-2024)Philips North America Llc2024-06-04
HA FlexTrak-Patient transport functionality to transport the patient from the preparation recall (Z-1949-2024)Philips North America Llc2024-06-04
HA FlexTrak II-Patient transport functionality to transport the patient from the preparati recall (Z-1950-2024)Philips North America Llc2024-06-04
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 recall (Z-1850-2024)Philips North America Llc2024-05-17
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicat recall (Z-1851-2024)Philips North America Llc2024-05-17
Ingenia Ambition S, Magnetic Resonance System. recall (Z-1568-2024)Philips North America Llc2024-04-17
Ingenia Ambition X, Magnetic Resonance System. recall (Z-1569-2024)Philips North America Llc2024-04-17
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
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781 recall (Z-0715-2024)Philips North America2024-01-11
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7 recall (Z-2397-2023)Philips North America2023-08-11
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7 recall (Z-2400-2023)Philips North America2023-08-11