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Diagnostic Ultrasound System Acclarix GX9

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref Acclarix GX9510(k) K192879Ref Acclarix LX85SRef Acclarix AX9 BasicRef Acclarix AX8

by Edan Instruments, Inc.

Identity

Trade Name
Diagnostic Ultrasound System EUDAMEDFDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
Diagnostic Ultrasound System EUDAMED
Model / Reference
Acclarix GX9 EUDAMED
Acclarix AX8 EUDAMEDFDA UDI
Acclarix AX9 Basic EUDAMEDFDA UDI
Acclarix LX85S EUDAMED

Identifiers

Primary DI / UDI-DI
06944413835498 EUDAMED
06944413802285 EUDAMEDFDA UDI
06944413816978 EUDAMEDFDA UDI
06944413847750 EUDAMED
Basic UDI-DI
69444138AcclarixGX9SD8 EUDAMED
69444138AcclarixLX9SEB EUDAMED
69444138AcclarixAX8SBT EUDAMED
510(k) Number
K192879 FDA 510(k)
K250214 FDA UDI
FDA Product Code
IYN FDA 510(k)FDA UDI
IYO FDA UDI
ITX FDA UDI
EMDN Code
Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Diagnostic Ultrasound System Acclarix GX9 is a Class IIa medical device classified under nomenclature code Z11040101, designed for diagnostic imaging using ultrasound technology. It functions as a non-invasive imaging tool to visualize internal body structures, aiding in the assessment of organs, tissues, and potential pathologies through real-time sound wave visualization.

This system is non-sterile, non-reusable, and non-implantable, intended for single-use applications in clinical settings. It is active and equipped with measuring functions, adhering to FDA 510K and MDR regulatory standards. Supplied as a standalone unit, it requires proper storage and handling as specified by the manufacturer to ensure operational integrity and compliance with medical device regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Edan Diagnostics, Ultrasound-Edan, Edan 理邦仪器, Edanultrasounds.com

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Edan Instruments, Inc.
EUDAMED SRN
CN-MF-000009957
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (7)

  • EUDAMED a0935a41-18df-4587-a453-49eaeccc0d0e 61 fields · synced Sep 18, 2026
  • FDA 510(k) K192879 24 fields · synced May 18, 2026
  • FDA UDI 35e40e62-e59b-46ec-9c6a-954ca74c2601 32 fields · synced May 30, 2026
  • FDA UDI 73248d84-4069-4ae5-8512-5b5bac6bc239 33 fields · synced May 30, 2026
  • EUDAMED bfcf1ed3-e76c-4c30-b5c6-526a7bb41336 61 fields · synced Jul 15, 2026
  • EUDAMED a2b1d413-b03c-4d43-98f2-44078f303d02 61 fields · synced Jul 21, 2026
  • EUDAMED f2652f1f-ab9f-4061-9447-0058a070181f 61 fields · synced Jul 23, 2026