Heartlab, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Heartlab, Inc. makes
Heartlab, Inc. develops and modifies medical imaging and diagnostic systems, including an ultrasound capture system for capturing and processing echocardiographic images, a DICOM-compatible viewer for cardiovascular imaging, and an ECG management system for organizing and analyzing cardiac data. Their portfolio also includes software modifications for existing cardiac diagnostic tools and an integrated cardiovascular imaging platform for clinical workflows.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. Their systems are listed in the FDA’s 510(k) premarket notification database, and the manufacturer is based in the United States.
Catalogue
Echonet Ref K954860
Regimes: 510(k) Registry: 510(k)Ultrasound Capture System Ref K042042
Regimes: 510(k) Registry: 510(k)Ascentia Heartstation Ecg Management System Ref K050858
Regimes: 510(k) Registry: 510(k)Dicomview Ref K954479
Regimes: 510(k) Registry: 510(k)Modification To Encompass Ref K040896
Regimes: 510(k) Registry: 510(k)Agfa Heartlab Cardiovascular Ref K050228
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heartlab, Inc. have in the registry?
The registry currently lists 6 devices for Heartlab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartlab, Inc.'s devices?
Among its 6 most recently registered devices, Heartlab, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Heartlab, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Heartlab, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heartlab, Inc. in the registry?
The most recently registered devices listed for Heartlab, Inc. include ECHONET, ULTRASOUND CAPTURE SYSTEM, ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM and DICOMVIEW.