Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029744051

FEI Number

3029744051

Entity Name

LYSIS HEALTHCARE GMBH

City/State/Country

Graz Steiermark, AT

Establishment Address

Grillweg 24, Graz Steiermark 8053, AT

Establishment Type(s)

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

Owner / Operator

Lysis Healthcare GmbH (Owner Number: 10093389)

Owner / Operator Contact Address

Grillweg 24, Graz, AT-6 8053, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122327

PMA Number

N/A

All Registered Proprietary Names

Transducer: 9026 (X12C4) Transducer: 9067 (E14C4) Transducer: 9015 (114C5I) Transducer: 9016 (114C5T) Ultrasound System 1300 Transducer: 9018 (E14C4t) Transducer: 9085 (5Cle) Transducer: 9038 (X14L4) Transducer: 9022 (10L2w) Transducer: 9062 (N13C5) Transducer: 9029 (E13C2) Transducer: 9002 (9C2) Transducer: 9032 (8L2) Transducer: 9086 (14L3e) Transducer: 9081 (18L5s) Transducer: 9087 (5Ple) Transducer: 9051 (14L3) Transducer: 9024 (112C5b) Transducer: 9009 (X18L5s) Transducer: 9008 (E11C3b) Transducer: 9048 (E14CL4b) Transducer: 9011 (13L4w) Transducer: 9023 (6C2s) Transducer: 9070 (18L5) Transducer: 9063 (N11C5s) Transducer: 9019 (E10C4) Transducer: 9040 (6C2) Transducer: 9052 (20R3) VOLUSON E6/E8/E8EXPERT/E10

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	2025-05-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-05-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-05-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-03-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-03-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-03-05

Official Correspondent

Sebastian Tautscher

US Agent Details

Robert Grzeskowiak Business: Midwest Imaging Corp. Email: info@mwimaging.com Phone: (636) 9250030

Related Public Records

Same Entity

Lysis Healthcare GmbH

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
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3025786376	ACO HEALTHCARE CO., LTD.	Taoyuan City, TW
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 3029744051. Last updated year: 2026. Please use registration number 3029744051 when referencing this establishment in official correspondence.