Optiscan Pty., Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
What Optiscan Pty., Ltd. makes
Optiscan Pty. Ltd. manufactures the OPTISCAN Model OPTISCAN CEIS, a device designed for electrocardiographic imaging (ECIS) to visualize cardiac electrical activity.
The company’s portfolio is regulated under Class II devices in the US, with the OPTISCAN CEIS listed via FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Optiscan Model Optiscan Ceis Ref K093624
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optiscan Pty., Ltd. have in the registry?
The registry currently lists 1 device for Optiscan Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optiscan Pty., Ltd.'s devices?
Among its 1 most recently registered device, Optiscan Pty., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Optiscan Pty., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Optiscan Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optiscan Pty., Ltd. in the registry?
The most recently registered devices listed for Optiscan Pty., Ltd. include OPTISCAN MODEL OPTISCAN CEIS.