Calgary Scientific, Inc.
CanadaFDA applicant, unverified
- Devices
- 8
What Calgary Scientific, Inc. makes
Calgary Scientific, Inc. manufactures software-based cardiac monitoring systems under the ResolutionMD brand, including desktop, web-based, and mobile versions designed for real-time electrocardiogram (ECG) analysis and patient monitoring. These products support clinical decision-making with features tailored for cardiac assessment, such as arrhythmia detection and waveform interpretation. The portfolio includes both standalone and integrated solutions for hospital, telemetry, and remote monitoring environments.
The company’s devices fall under Class II regulatory classification in the U.S., with each product authorised through FDA 510(k) clearance. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Resolutionmd, Version 1.3 Ref K062164
Regimes: 510(k) Registry: 510(k)Resolutionmd Web Ref K120076
Regimes: 510(k) Registry: 510(k)Resolutionmd, Release 2.1 Ref K082693
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Resolutionmd Mobile Ref K133508
Regimes: 510(k) Registry: 510(k)Resolutionmd Mobile Model Rmb-Mob-2X Ref K111346
Regimes: 510(k) Registry: 510(k)ResolutionMD Ref K161130
Regimes: CE MDR 510(k) Registry: 510(k)Resolutionmd Mobile 3.1 Model Rmd-Mob-31 Ref K123186
Regimes: CE MDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Calgary Scientific, Inc. have in the registry?
The registry currently lists 8 devices for Calgary Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calgary Scientific, Inc.'s devices?
Among its 8 most recently registered devices, Calgary Scientific, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Calgary Scientific, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Calgary Scientific, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calgary Scientific, Inc. in the registry?
The most recently registered devices listed for Calgary Scientific, Inc. include RESOLUTIONMD, VERSION 1.3, RESOLUTIONMD WEB, RESOLUTIONMD, RELEASE 2.1 and RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0.