Magnetic Resonance Imaging Systems 782147

GUDID 00884838108707

Upgrades Achieva/Intera to R11

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet
Primary Device ID00884838108707
NIH Device Record Key5acf96ed-b707-473f-93f8-a01eb5028068
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagnetic Resonance Imaging Systems
Version Model NumberUpgrades Achieva/Intera to R11
Catalog Number782147
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838108707 [Primary]

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-31
Device Publish Date2025-12-23

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838104402 - Ingenia2026-02-04 Upgrade to MR 7700
00884838128415 - Ingenia 2026-01-15 BlueSeal SE
00884838128422 - Ingenia 2026-01-15 BlueSeal XE
00884838128439 - Ingenia 2026-01-15 MR 7700
00884838128446 - Ingenia 2026-01-15 MR 5300
00884838128453 - Ingenia 2026-01-15 Ingenia Elition S
00884838128460 - Ingenia 2026-01-15 Ingenia Elition X
00884838128477 - Ingenia, MR5300, MR7700, Achieva2026-01-15 Ingenia Ambition S

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