Ingenia Ambition X

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 782138

by Philips Medical Systems Nederland B.V.

Identity

Trade Name: Ingenia Ambition X EUDAMED
Ingenia FDA UDI
Generic Name: Full-body MRI system, superconducting magnet FDA UDI
Device Name: Magnetic Resonance Imaging Systems EUDAMED
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. FDA UDI
Model / Reference: 782138 EUDAMED
Ingenia Ambition X FDA UDI
Description: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. FDA UDI

Identifiers

Catalog Number: 782138 FDA UDI
Primary DI / UDI-DI: 00884838108622 EUDAMEDFDA UDI
Basic UDI-DI: 0884838BM697TZ EUDAMED
Direct Marketing DI: 00884838108622 EUDAMED
510(k) Number: K213583 FDA UDI
FDA Product Code: LNH FDA UDI
LNI FDA UDI
EMDN Code: Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
GMDN Term: Full-body MRI system, superconducting magnet FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Full-body MRI system, superconducting magnet

Ingenia Ambition X by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full-body MRI system, superconducting magnet.

iTX Extremity 18 Flare Coil set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
MAGNETOM Sola Fit — Siemens Healthcare · Class II
8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0884838BM697TZ	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Philips Medical Systems Nederland B.V.
EUDAMED SRN: NL-MF-000001489

Sources (2)

EUDAMED 011438b6-52e5-43c5-8394-3907b0b0cdda 61 fields · synced Sep 18, 2026
FDA UDI 7ad12d1d-664c-4818-a445-07786a3f784c 36 fields · synced May 29, 2026