Sure Inc.
Country not established
- Devices
- 3
What Sure Inc. makes
Sure Inc. manufactures electronic clinical breast examination systems designed to map pressure distribution, including portable and stationary models for diagnostic use. These devices are intended to assist in assessing tissue compression during examinations, such as mammography or ultrasound. The systems include components like pressure sensors and software for real-time data visualization.
The company’s products fall under FDA Class II regulation, requiring premarket notification (510(k)) submissions and inclusion in the FDA’s Unique Device Identifier (UDI) database. These devices are listed under the relevant FDA registries for Class II medical devices, ensuring compliance with U.S. regulatory standards. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
SureTouch Mobile Pressure Mapping System Ref K181672
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 116944848
- [email protected]
- Phone
- (833) 787-3462
Frequently asked questions
How many devices does SURE INC. have in the registry?
The registry currently lists 3 devices for SURE INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SURE INC.'s devices?
Among its 3 most recently registered devices, SURE INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SURE INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for SURE INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from SURE INC. in the registry?
The most recently registered devices listed for SURE INC. include SureTouch Mobile Pressure Mapping System 1885, Bexa Pressure Mapping System 1885 and SureTouch Mobile Pressure Mapping System.