510(k) K200132 ยท LLZ System, Image Processing, Radiological
Ashvins
| Applicant | Medicalcommunications GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, Feb 18, 2020 |
| Received | Jan 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | MedicalCommunications GmbH Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Device Type: Software (Medical Image Management, Picture Archiving and Communication System) Open, Classified |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.