Achieva 1.5T

GUDID 00884838055292

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet
Primary Device ID00884838055292
NIH Device Record Key44d3e5e0-438a-4414-8961-aa864f9ed167
Commercial Distribution StatusIn Commercial Distribution
Brand NameAchieva 1.5T
Version Model Number781343
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838055292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNISystem, nuclear magnetic resonance spectroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838108707 - Magnetic Resonance Imaging Systems2025-12-31 Upgrades Achieva/Intera to R11
00884838117921 - Spectral CT 7500 RT2025-12-31
00884838118300 - MR Coils2025-12-31 dS Wrist Coil 8ch 1.5T
00884838118317 - MR Coils2025-12-31 dS FootAnkle Coil 8ch 1.5T
00884838118409 - MR Coils2025-12-31 dS Shoulder Coil 8ch 1.5T
00884838118430 - MR Coils2025-12-31 MR Coils
00884838123045 - DUNLEE2025-12-31 The 16 Breast Coil is a Phased Array Receive Only MRI Coil. It is a variable 16 CH Breast coil for both diagnostic imaging and b
00884838125773 - IntelliSpace Cardiovascular2025-12-23 Philips IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide cli

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.