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510(k) Data Aggregation
K Number
K050858Device Name
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
Manufacturer
HEARTLAB, INC.
Date Cleared
2005-06-29
(85 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
HEARTLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
Device Description
The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports
Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.
A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.
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K Number
K050228Device Name
AGFA HEARTLAB CARDIOVASCULAR
Manufacturer
HEARTLAB, INC.
Date Cleared
2005-02-18
(17 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEARTLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ascentia ™ (formally Encompass™) is a picture archiving and communications system intended to be used as a networked cardiovascular information and image data storage and display system. Ascentia™ is comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia™ accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors. The system provides the capability to, consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative analysis on cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive. Ascentia™ is a scalable network solution that can be used in small areas and departments (with 2 or 3 users) to large hospital networks (with tens of users).
Device Description
Ascentia is a picture archiving and communications system intended to be used as a networked cardiovascular information and image data storage and display system. Ascentia is comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors. The system provides the capability to, consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative analysis on cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive. Ascentia is a scalable network solution that can be used in small areas and departments (with 2 or 3 users) to large hospital networks (with tens of users).
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K Number
K042042Device Name
ULTRASOUND CAPTURE SYSTEM
Manufacturer
HEARTLAB, INC.
Date Cleared
2004-09-21
(54 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEARTLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.
Device Description
The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.
1. Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.
2. Performs automatic image acquisition triggered by the cine-pedal.
3. Performs network transmission of images in DICOM format to a DICOM compatible storage system.
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K Number
K040896Device Name
MODIFICATION TO ENCOMPASS
Manufacturer
HEARTLAB, INC.
Date Cleared
2004-07-16
(101 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEARTLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shel?' personal coonyters and servers running the Windows 2000/XP operating system. Encompass™ is image data surage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and on voview patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
Device Description
Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/XP operating system. Encompass™ is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users). The original core functionality is detailed below:
1. Review of x-ray angiography, ultrasound, intravascular ultrasound, computed tomography (CT), nuclear medicine, and magnetic resonance imaging (MRI) images.
2. Compare images from different studies on one or two monitors, regardless of modality.
3. Perform report data entry and view the report.
4. Print, save as mpeg/avi, save as bitmap, and copy to clipboard any image(s).
5. Perform standard image processing such as brightness, contrast, gamma, sharpen, window/level, invert, pan, zoom, and digital subtraction.
6. Perform standard stop, start, single frame advance and reverse, previous/next image playback, and various standard clinical presentations.
7. Control the speed of playback.
8. Use a supported jog wheel to control playback.
9. Play/repeat a subset of a loop with user defined begin and endpoints.
10. Search sources for studies based on demographic information.
11. Copy any study or subset of study from any supported source to any supported destination.
12. Write DICOM study to CD/DVD for interchange.
13. Calibrate the monitor to a SMPTE pattern.
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K Number
K954479Device Name
DICOMVIEW
Manufacturer
HEARTLAB, INC.
Date Cleared
1996-02-21
(148 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
HEARTLAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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