16ch Flex SPEEDER Large 1.5T

GUDID 00814848020829

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency
Primary Device ID00814848020829
NIH Device Record Keycaceb239-2d3c-4e1d-83e0-b84c1d77fd88
Commercial Distribution StatusIn Commercial Distribution
Brand Name16ch Flex SPEEDER Large 1.5T
Version Model NumberQ7000247
Company DUNS614760119
Company NameQUALITY ELECTRODYNAMICS LLC
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 Datetrue
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
GS100814848020829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

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00814848020829 - 16ch Flex SPEEDER Large 1.5T2025-05-28
00814848020829 - 16ch Flex SPEEDER Large 1.5T2025-05-28
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00814848020799 - Contour Shoulder2025-04-11
00814848020782 - 16ch T/R Hand Wrist Coil2024-07-26
00814848020508 - Shape Coil2021-08-30
00814848020546 - Shape Coil2021-08-30
00814848020515 - 2Tx 28Rx Knee Coil2021-02-22

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