Merge Cardio 12.3

Primary DI
00842000101109
Brand
Merge Cardio 12.3
Company
MERGE HEALTHCARE SOLUTIONS INC.
Model
12.3
Device description
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.
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192276000Merge CardioMerge Healthcare Incorporated2019-09-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842000101109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842000101109008420001011098420001011090842000101109

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Regulatory Flags#

DUNS number
065626069
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842000101239Merge PACS9.52026-05-07
00842000100614RadSuite 8.322019-09-25
00842000100904Merge OrthoTemplates40.2.22023-06-09
00842000100782IBM iConnect Access7.12019-04-30
00842000100713Merge OrthoCase3.7.52018-09-21
00842000100720IBM iConnect Access7.02018-10-26
00842000100683iConnect Access6.52019-05-10
00842000100126Merge iConnect Access6.32016-12-12
00842000100645Merge iConnect Access6.42017-10-17
00842000100041Merge Cardio10.32017-01-12
00842000100416Merge Cardio11.02017-09-05
00842000100591Merge Cardio10.12017-02-10
00842000100874Merge Hemo 10.32020-04-23
00842000101031CADstream6.42021-09-21
00842000100881CADstream6.32021-02-08
00842000100638CADstream6.22019-04-26
00842000100027Merge Hemo9.42021-09-21
00842000100010Merge Hemo10.0.42016-11-30
00842000100034Merge HEMO10.12017-10-19
00842000100430Merge Hemo 10.22019-06-27

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