FDA.reportPublic FDA data

SuperSonic HepaVu

Primary DI
03760193600384
Brand
SuperSonic HepaVu
Company
Supersonic Imagine, Inc.
Model
ASY-HEPA-INTL
Catalog number
ASY-HEPA-INTL
Device description
SuperSonic HepaVu
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242223000SuperSonic HepaVuSupersonic Imagine2024-09-20IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760193600384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760193600384037601936003843760193600384

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)442992424contactsFR@supersonicimagine.com

Regulatory Flags#

DUNS number
034094134
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760193600223LV16-5 TransducerSSIP95108SSIP951082023-02-21
03760193600230SUPERSONIC MACH 20SSIP95020-HOLXSSIP95020-HOLX2023-02-21
03760193600254SUPERSONIC MACH 30SSIP95030-HOLXSSIP95030-HOLX2023-02-21
03760193600308AIXPLORER MACH 20 - 220V SYSTEMSSIP95020SSIP950202023-02-21
03760193600001SEV12-3 GEN II®SSIP93189SSIP931892016-10-17
03760193600018Aixplorer®SSIP92029SSIP920292016-10-17
03760193600025SL15-4 Gen II®SSIP92002SSIP920022016-10-17
03760193600032SC6-1 Gen II®SSIP92030SSIP920302016-10-17
03760193600049AIXPLORER VSSIP92188SSIP921882016-10-17
03760193600056SE12-3 Gen II®SSIP92068SSIP920682016-10-17
03760193600063SL10-2 Gen II®SSIP92085SSIP920852016-10-17
03760193600070SMC12-3 Gen II®SSIP92097SSIP920972016-10-17
03760193600087XP5-1®SSIP92161SSIP921612016-10-17
03760193600094SLH20-6®SSIP92164SSIP921642016-10-17
03760193600100SC6-1 Gen I®SSIP90030SSIP900302016-10-17
03760193600117SLV16-5 Gen I®SSIP92164SSIP921642016-10-17
03760193600124SUPERSONIC MACH 40SSIP95040SSIP950402016-10-17
03760193600131AIXPLORER MACH 30 - 220V SYSTEMSSIP95030SSIP950302016-10-17
03760193600148SMC12-3 Gen I®SSIP90097SSIP900972016-10-17
03760193600155XC6-1®SSIP92030SSIP920302016-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAIYO2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08056304452658MyLab 9 eXPESAOTE SPAITX2018-02-19
08056304452658MyLab 9 eXPESAOTE SPAIYN2018-02-19
08056304452603MyLabEight eXPESAOTE SPAIYO2017-04-03
08056304452603MyLabEight eXPESAOTE SPAIYN2017-04-03
08056304452610MyLabEightESAOTE SPAITX2017-04-03
08056304452610MyLabEightESAOTE SPAIYO2017-04-03
08056304452597MyLabSeven ESAOTE SPAITX2017-02-24
08056304452597MyLabSeven ESAOTE SPAIYO2017-02-24
08056304453013MyLabOneEsaote Europe B.V.ITX2017-02-24