# K051649: Vericis Cardiovascular Image and Information System, Model 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Camtronics Medical Systems
- Decided: Aug 2, 2005 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922164 (1993). 7 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043146: Horizon Medical Imaging, Mckesson Medical Imaging Company (2005) Summary page 1.

## Most influential descendants
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own
- K122205: EXINI (2012), 5 descendants of its own
- K191262: aBSI (2019), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own

## Recalls of this device
- Feb 19, 2025 · Class II · Z-1401-2025: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, deriv
- Feb 19, 2025 · Class II · Z-1398-2025: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, deriv
- Feb 19, 2025 · Class II · Z-1399-2025: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, deriv
- Feb 19, 2025 · Class II · Z-1400-2025: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, deriv
- May 8, 2020 · Class II · Z-2403-2020: An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting i
- Apr 13, 2016 · Class II · Z-2123-2017: Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced
- Apr 4, 2016 · Class II · Z-1486-2017: Cardio study list does not show STAT studies without refreshing.
- Apr 4, 2016 · Class II · Z-1415-2017: A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
- Apr 4, 2016 · Class II · Z-1403-2017: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
- Mar 28, 2016 · Class II · Z-0729-2017: If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorr
- Mar 28, 2016 · Class II · Z-1046-2017: If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all curren
- Feb 9, 2016 · Class II · Z-2709-2016: A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
- Jan 30, 2016 · Class II · Z-2865-2016: Patient information in the header is only found on the first page of the report and not on the subsequent pages.
- Oct 26, 2015 · Class II · Z-0555-2016: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
- Oct 1, 2015 · Class II · Z-0730-2017: Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
- Sep 22, 2015 · Class II · Z-1496-2017: For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have
- Sep 22, 2015 · Class II · Z-1517-2017: Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.

## Indications for use
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician-generated clinical reports (via structure reporting and template based tools), and to store this information in a database. *VERICIS is software comprised of modules that perform under standard "off-the-shelf' personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems. eVERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML. eVERICIS is an Intemet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.

Source page: https://510kreport.com/device/K051649
Methodology: https://510kreport.com/methodology