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.

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00884838119284 - Philips Sentinelle2024-12-25 dS 3.0T Interface Box
00884838119291 - Philips Sentinelle2024-12-25 dS 1.5T 8CH Medial
00884838119307 - Philips Sentinelle2024-12-25 dS 3.0T 8CH Medial
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00884838119321 - Philips Sentinelle2024-12-25 dS 3.0T 4CH Lateral Left
00884838119338 - Philips Sentinelle2024-12-25 dS 1.5T 4CH Lateral Right

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