Merge Cardio
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized…
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Merge Healthcare Solutions Inc. |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K192276 |
| Record published | 2022-11-09 |
| Record revised | 2026-04-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-02-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12.2 | In distribution | |
| 12.1 | In distribution | |
| 12.0.1 | In distribution | |
| 12.5 | In distribution | |
| 12.4 | In distribution | |
| 10.3 | Withdrawn | |
| 10.1 | Withdrawn | |
| 11.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
Recalls Naming This Product
18 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merge Healthcare Incorporated | 510(k) number | 2025-02-19 | Class II | Software design | 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, derived measurements may be inconsistent with | 2 | |
| Merge Healthcare Incorporated | 510(k) number | 2025-02-19 | Class II | Software design | 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, derived measurements may be inconsistent with | 11 | |
| Merge Healthcare Incorporated | 510(k) number | 2025-02-19 | Class II | Software design | 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, derived measurements may be inconsistent with | 66 | |
| Merge Healthcare Incorporated | 510(k) number | 2025-02-19 | Class II | Software design | 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, derived measurements may be inconsistent with | 37 | |
| Merge Healthcare Incorporated | UDI-DI | 2025-02-19 | Class II | Software design | 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, derived measurements may be inconsistent with | 253 | |
| Merge Healthcare Incorporated | 510(k) number | 2020-05-08 | Class II | Software Design Change | 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 in a false negative. | 62 units | 2023-06-23 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-13 | Class II | Software design | 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. | 30 sites have the potentially affected software versions | 2017-07-17 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | 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. | 110 sites potentially have the affected versions | 2019-07-26 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | 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. | 17 sites potentially have the affected versions | 2017-03-20 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | Cardio study list does not show STAT studies without refreshing. | 217 sites potentially have the affected versions | 2019-07-26 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-28 | Class II | Software design | 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 incorrect accession number (but still associat | 198 sites potentially have the effected versions | 2020-03-20 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-28 | Class II | Software design | 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 current images will be present for review, whi | 188 sites potentially have the effected versions | 2019-04-08 |
| Merge Healthcare Incorporated | 510(k) number | 2016-02-09 | Class II | Software design | 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). | 116 customers potentially have the affected versions | 2017-08-24 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | Patient information in the header is only found on the first page of the report and not on the subsequent pages. | 42 sites potentially have the affected version | 2017-12-15 |
| Merge Healthcare Incorporated | 510(k) number | 2015-10-26 | Class II | Process control | 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. | 1 | 2016-07-22 |
| Merge Healthcare Incorporated | 510(k) number | 2015-10-01 | Class II | Software design | 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. | 116 sites potentially have the effected versions | 2018-03-23 |
| Merge Healthcare Incorporated | 510(k) number | 2015-09-22 | Class II | Process design | 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 the first name, last name, and medical | 16 sites were originally identified as potentially having th | 2017-04-18 |
| Merge Healthcare Incorporated | 510(k) number | 2015-09-22 | Class II | Software design | 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. | 89 sites potentially have the affected software | 2019-08-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.