510(k) K051649 ยท LLZ System, Image Processing, Radiological
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
| Applicant | Camtronics Medical Systems, Hartland WI, US |
| Decision | Substantially Equivalent, Aug 2, 2005 |
| Received | Jun 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a
picture archiving and communicat Open, Classified |
LLZ | None listed |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified a Open, Classified |
LLZ | None listed |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a pictur Open, Classified |
LLZ | None listed |
| Mar 20, 2025 | Merge Healthcare, Inc. VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and commun Open, Classified |
LLZ | None listed |
| May 8, 2020 | Merge Healthcare, Inc. Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, pr Terminated |
LLZ | None listed |
| May 22, 2017 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Intended to be used to acquire, store, print, transfer, and archive clinical information. Terminated |
LLZ | None listed |
| Mar 20, 2017 | Merge Healthcare, Inc. Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Mar 8, 2017 | Merge Healthcare, Inc. Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Mar 3, 2017 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Sep 1, 2016 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. Terminated |
LLZ | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Cardio software. Terminated |
LLZ | None listed |
| Mar 28, 2016 | Merge Healthcare, Inc. Merge Cardio software.
Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measureme Terminated |
LLZ | None listed |
| Mar 28, 2016 | Merge Healthcare, Inc. Merge Cardio software.
Product Usage:
Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and rep Terminated |
LLZ | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. Merge Cardio software.
Product Usage:
Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. Terminated |
LLZ | None listed |
| Oct 26, 2015 | Merge Healthcare, Inc. Merge Cardio with software version 10.1 LA. Terminated |
LLZ | None listed |
| Oct 1, 2015 | Merge Healthcare, Inc. Merge Cardio software.
Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Terminated |
LLZ | None listed |
| Sep 22, 2015 | Merge Healthcare, Inc. Merge Cardio software.
Product Usage:
Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and rep Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.