Resoundant Acoustic Driver System

GUDID 00850011790021

RESOUNDANT, INC.

Magnetic resonance elastography acoustic driver
Primary Device ID00850011790021
NIH Device Record Key4544839d-e5d9-4602-bfcc-b45fc0a70b5a
Commercial Distribution Discontinuation2021-11-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameResoundant Acoustic Driver System
Version Model NumberRESY3002-RESYSAB
Company DUNS036969003
Company NameRESOUNDANT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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
GS100850011790021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-02-12
Device Publish Date2021-05-01

Devices Manufactured by RESOUNDANT, INC.

00850011790021 - Resoundant Acoustic Driver System2026-02-12
00850011790021 - Resoundant Acoustic Driver System2026-02-12
00850011790267 - Active Driver v22025-09-11
00850011790229 - Pillow Passive Driver Kit2024-10-11
00850011790045 - Flex Passive Driver Kit- Large2023-04-10
00850011790052 - Flex Passive Driver Kit- Small2023-04-10
00850011790106 - Passive Driver2023-03-01
00850011790199 - Hepatogram Plus 2022-04-21
00850011790007 - MREplus2021-04-09

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