FDA.reportPublic FDA data

Ingenia

Primary DI
00884838098336
Brand
Ingenia
Company
Philips Medical Systems Nederland B.V.
Model
Ingenia Elition X
Catalog number
782107
Device description
Ingenia Elition X
Published
2021-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, radiation therapy, charged-particle, medical
LNHSystem, nuclear magnetic resonance imaging
LNISystem, Nuclear Magnetic Resonance Spectroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
LNISystem, Nuclear Magnetic Resonance SpectroscopicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193215000Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.2020-04-10LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838098336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838098336008848380983368848380983360884838098336

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377xx@xx.xx

Regulatory Flags#

DUNS number
413819707
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838127746Radiology Operations Command Center Console18080072025-03-14
00884838122154EchoNavigatorEchoNavigator R5.00010112026-03-25
00884838107557Image Management15.X8390602024-11-15
00884838107571Desktop Diagnostic Viewer15.X8390622024-11-15
00884838107588Web Diagnostic Viewer15.X8390632024-11-15
00884838107595Enterprise Viewer15.X8390642024-11-15
00884838101883Dynamic Coronary RoadmapDynamic Coronary Roadmap - 30010162020-11-10
00884838101890StentBoost LiveStentBoost Live - 20010172020-11-10
00884838106437EchoNavigatorEchoNavigator - 42023-02-10
00884838103504Vue PACS (Web Diagnostic)Vue PACS (Web Diagnostic) - 1289860102021-06-03
00884838085732SmartCTSmartCT - 10010182021-02-25
00884838090668Onvision systemOnvision system4535619434922020-08-07
00884838100336Vue PACSVue PACS - 1289864242020-05-18
00884838100350Vue PACS (Diagnostic)Vue PACS (Diagnostic) - 1211494182020-05-18
00884838100367Vue MotionVue Motion - 1210179792020-05-18
00884838059184EP navigatorEP navigator - 50000712016-09-24
00884838059191Interventional WorkspotInterventional Workspot - 10010002016-09-24
00884838059207HeartNavigatorHeartNavigator - 20010012016-09-24
008848380592213D Roadmap3D Roadmap - 10010032016-09-24
00884838059238MR-CT RoadmapMR-CT Roadmap - 10010042016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21
00850065937151eMotusEMPNIA INC.LHN2026-09-21
00850065937168eMotusEMPNIA INC.LHN2026-09-21
00850065937175eMotusEMPNIA INC.LHN2026-09-21
00850065937182eMotusEMPNIA INC.LHN2026-09-21
00850065937199eMotusEMPNIA INC.LHN2026-09-21
00850065937205eMotusEMPNIA INC.LHN2026-09-21
00850065937212eMotusEMPNIA INC.LHN2026-09-21
00850065937229eMotusEMPNIA INC.LHN2026-09-21
00850065937236eMotusEMPNIA INC.LHN2026-09-21
00850065937243eMotusEMPNIA INC.LHN2026-09-21
00850065937250eMotusEMPNIA INC.LHN2026-09-21
00850065937267eMotusEMPNIA INC.LHN2026-09-21
00850065937274eMotusEMPNIA INC.LHN2026-09-21
00850065937298eMotusEMPNIA INC.LHN2026-09-21
00850065937304eMotusEMPNIA INC.LHN2026-09-21