FDA.reportPublic FDA data

SureWave Elastography

Primary DI
00814848020775
Brand
SureWave Elastography
Company
QUALITY ELECTRODYNAMICS LLC
Model
Q7000225
Published
2025-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242006000SureWave Elastography (Q7000225)Quality Electrodynamics, LLC2025-02-12LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814848020775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814848020775008148480207758148480207750814848020775

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic resonance elastography acoustic driverAn assembly of devices, consisting of an electrically-powered pneumatic wave generator and a noninvasive vibration applicator, intended for use with a magnetic resonance imaging (MRI) system to provide a measure of tissue elasticity/stiffness. The generator is used outside the MRI scanner room and is connected by pneumatic tubing to the applicator, which is applied to the site of interest on the patient’s body while within the MRI scanner. The pneumatically-transferred vibrations are applied to the body and MRI images are taken to facilitate evaluation/diagnosis of the condition of tissues (e.g. liver, brain), including damage and tumours.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614760119
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814848020836Contour Hand Wrist 0.55TQ70002322026-04-23
0081484802081216ch Flex SPEEDER Medium 1.5TQ70002462025-05-20
0081484802082916ch Flex SPEEDER Large 1.5TQ70002472025-05-20
00814848020799Contour ShoulderQ70002222025-04-03
0081484802078216ch T/R Hand Wrist CoilQ70002382024-07-18
00814848020751Contour KneeQ70001872023-01-19
008148480205152Tx 28Rx Knee CoilQ70001882021-02-12
0081484802024916ch T/R Hand Wrist CoilQ70001802018-01-30
00814848020256Contour 24Q70001842018-06-04
00814848020508Shape CoilQ70001992021-08-20
00814848020546Shape CoilQ70001982021-08-20
00814848020423Contour 24Q70001832019-03-21
0081484802000318ch T/R Knee CoilQ70000742016-09-16
00814848020010Atlas SPEEDER Head/Neck CoilQ70001462016-09-16
00814848020027Wrist SPEEDER CoilQ70000052016-09-16
00814848020034Tx/Rx Extra Large Knee CoilQ70000062016-09-16
00814848020041TxRx 15ch Knee CoilQ70000082016-09-16
00814848020065TxRx 15ch Knee CoilQ70000162016-09-16
00814848020089Shoulder SPEEDER CoilQ70000182016-09-16
00814848020096TxRx CP Extremity CoilQ70000192016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19