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SuperSonic HepaVu

by Supersonic Imagine

510(k) K242223Ref ASY-HEPA-INTL

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242223↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03760193600384 UDI-DI Date10 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number376019360HepaVuYH Basic UDI-DI 03760193600384UDI-DIDate11 Dec 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK242223 Date20 Sep 2024ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 376019360HepaVuYH registered 11 Dec 2024 Active
  • FDA 510(k) K242223 decided 20 Sep 2024 Active
  • FDA GUDID UDI-DI 03760193600384 listed 10 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242223
  2. Registered EUDAMED 376019360HepaVuYH
  3. Listed FDA GUDID 03760193600384

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
General-purpose ultrasound imaging system
Model / Ref / Catalog
ASY-HEPA-INTL
Primary DI / UDI-DI
03760193600384
Basic UDI-DI
376019360HepaVuYH
510(k) Number
FDA product code
IYN, ITX, IYO
EMDN code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1550 510(k)GUDID
892.1570 GUDID
892.1560 GUDID
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SuperSonic HepaVu is a contrast-enhanced ultrasound imaging device designed for visualizing blood vessels and tissue perfusion. It employs microbubble contrast agents to enhance ultrasound imaging, improving the detection and assessment of vascular structures and abnormalities within soft tissues.

This device is intended for use in clinical settings such as radiology departments and is supplied as a reusable system. It operates under FDA 510K clearance and MDR authorization, adhering to regulatory standards for medical imaging equipment. The device is not classified as single-use and requires proper maintenance and storage as per manufacturer guidelines to ensure optimal performance and safety.

Devices cleared under K242223

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K242223
UDI-DISize and differences
SuperSonic HepaVu ASY-HEPA-INTL
Supersonic Imagine, Inc.
ASY-HEPA-INTL / ASY-HEPA-INTL03760193600384 —On the market

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Other devices filed under MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.).

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)