Sota Precision Optics, Inc. Dba Sota Imaging
United StatesFDA applicant, unverified
- Devices
- 2
What Sota Precision Optics, Inc. Dba Sota Imaging makes
Sota Precision Optics, Inc. manufactures digital imaging systems for dental use, including intraoral cameras like the Clio Prime and Clio Pedo, designed for capturing high-resolution images of teeth and oral structures. The company also produces cloud-based imaging solutions, such as the SOTA Cloud Imaging platform, which supports remote storage and sharing of dental radiographs and photographs.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with applicable US regulatory requirements. The manufacturer is based in the United States.
Catalogue
SOTA Cloud Imaging Ref K210682
Regimes: 510(k) Registry: 510(k)Clio Prime and Clio Pedo Ref K202664
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sota Precision Optics, Inc. Dba Sota Imaging have in the registry?
The registry currently lists 2 devices for Sota Precision Optics, Inc. Dba Sota Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sota Precision Optics, Inc. Dba Sota Imaging's devices?
Among its 2 most recently registered devices, Sota Precision Optics, Inc. Dba Sota Imaging has devices listed in FDA 510(k) (2 devices).
What risk classes do Sota Precision Optics, Inc. Dba Sota Imaging's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sota Precision Optics, Inc. Dba Sota Imaging's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sota Precision Optics, Inc. Dba Sota Imaging in the registry?
The most recently registered devices listed for Sota Precision Optics, Inc. Dba Sota Imaging include SOTA Cloud Imaging and Clio Prime and Clio Pedo.