Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025786376

FEI Number

3025786376

Entity Name

ACO HEALTHCARE CO., LTD.

City/State/Country

Taoyuan City, TW

Establishment Address

1F, No.8-1, Nandong Rd., Pingzhen Dist, Taoyuan City 324, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Aco Healthcare Co., Ltd. (Owner Number: 10089889)

Owner / Operator Contact Address

1F, No.8-1, Nandong Rd., Pingzhen Dist, Taoyuan City, TW-TAO 324, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231509

PMA Number

N/A

All Registered Proprietary Names

neo Medical Ultrasound System (model: neo L187) Aco Apache Ultrasound System (model: neo L154) neo Medical Ultrasound System (model: neo P42) Aco Apache Ultrasound System (model: L154) neo Medical Ultrasound System (model: neo L154) neo Medical Ultrasound System (model: neo C62) Aco Apache Ultrasound System (model: neo C62) Aco Apache Ultrasound System (model: neo P42) Aco Apache Ultrasound System (model: C62) Aco Apache Ultrasound System (model: neo L187) Aco Apache Ultrasound System (model: neo P3H)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-01-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-01-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-01-18

Official Correspondent

Henry Huang

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Aco Healthcare Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number	Establishment Name	Location
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3004752776	Compumedics Germany GmbH	Singen Baden-Wurttemberg, DE
1528028	FUJIFILM Healthcare Americas Corporation	Twinsburg, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025786376. Last updated year: 2026. Please use registration number 3025786376 when referencing this establishment in official correspondence.