Atlas FDA

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

FDA 510(k) clearance K193215 · decided 2020-04-10

Clearance details

K-number
K193215
Device name
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2019-11-21
Decision date
2020-04-10
Days to decision
141 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 Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model N recall (Z-1951-2026)Philips North America2026-04-27
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. recall (Z-1953-2026)Philips North America2026-04-27
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 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 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7 recall (Z-1965-2026)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
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 recall (Z-1206-2026)Philips North America2026-01-29
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 recall (Z-1207-2026)Philips North America2026-01-29
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. recall (Z-1208-2026)Philips North America2026-01-29
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1 recall (Z-1209-2026)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
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with recall (Z-1211-2026)Philips North America2026-01-29
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with recall (Z-1212-2026)Philips North America2026-01-29
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781 recall (Z-2200-2025)Philips North America2025-07-30
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; recall (Z-2201-2025)Philips North America2025-07-30
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 1.5T S Model Number (REF): 781347; recall (Z-2205-2025)Philips North America2025-07-30
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; recall (Z-2206-2025)Philips North America2025-07-30
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; recall (Z-2207-2025)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
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (Chi recall (Z-2210-2025)Philips North America2025-07-30
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) recall (Z-2211-2025)Philips North America2025-07-30
Intera 3.0T Quasar Dual Model Number (REF): 781150; recall (Z-2212-2025)Philips North America2025-07-30
Achieva XR Product Numbers: (1) 781153, (2) 781253; recall (Z-1928-2025)Philips North America2025-06-09
Intera 1.5T Achieva IT Nova Product Number: 781175 recall (Z-1929-2025)Philips North America2025-06-09
Intera 1.5T Achieva Nova Product Number: 781172; recall (Z-1930-2025)Philips North America2025-06-09
Intera 1.5T Achieva Nova-Dual Product Number: 781173; recall (Z-1931-2025)Philips North America2025-06-09
Intera 1.5T Explorer/Nova Dual Product Number: 781108; recall (Z-1932-2025)Philips North America2025-06-09
Intera 1.5T Master/Nova Product Number: 781106; recall (Z-1933-2025)Philips North America2025-06-09
Intera 1.5T Omni/Stellar; Product Number: 781104; recall (Z-1934-2025)Philips North America2025-06-09
Intera Achieva 1.5T Pulsar; Product Number: 781171; recall (Z-1935-2025)Philips North America2025-06-09
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 1.5T S; Model Number: 781347; recall (Z-1796-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; recall (Z-1797-2025)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 1.5T CX; Model Number: 781262; recall (Z-1799-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 3.0T CX; Model Number: 781271; recall (Z-1800-2025)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
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137; recall (Z-1802-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; recall (Z-1803-2025)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 0.5T Standard, Model Number: 781101; recall (Z-1771-2025)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 1.0T Power/Pulsar, Model Number: 781103; recall (Z-1773-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
Intera 1.5T, Model Numbers: 781195 and 781295; recall (Z-1774-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15
Intera 1.5T Explorer/Nova Dual, Model Number: 781108; recall (Z-1775-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-05-15