Data / Medical devices / Austria / Lysis Healthcare GMBH
Lysis Healthcare GMBH: FDA-registered device maker in Graz Steiermark, Austria, 3 510(k) clearances
Lysis Healthcare GMBH is registered with the FDA (registration 3029744051) in Graz Steiermark, Austria. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029744051
- Address
- Grillweg 24, Graz Steiermark, Austria, 8053
- Owner or operator
- Lysis Healthcare GmbH (10093389)
- Roles
- Exporter to the US
- First device listed
- May 12, 2025
- Registered through
- 2026
- Brand names listed
- Siemens Acuson EC9-4, Transducer: 9002 (9C2), Transducer: 9008 (E11C3b), Transducer: 9009 (X18L5s), Transducer: 9011 (13L4w), Transducer: 9015 (114C5I), Transducer: 9016 (114C5T), Transducer: 9018 (E14C4t) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2018 | K173569 | Ultrasound System 1300 | IYN | Substantially Equivalent | Bk Medical Aps | accessdata.fda.gov |
| September 21, 2012 | K122327 | VOLUSON E6/E8/E8EXPERT/E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 22, 2012 | K121699 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Catheter, Intravascular, Diagnostic
Updated February 23, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.