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Sign in to claim this brandDIGISIGHT TECHNOLOGIES, INC.
US
Last updated May 31, 2026
What DIGISIGHT TECHNOLOGIES, INC. makes
Digisight Technologies, Inc. manufactures ophthalmic fundus cameras, including the Paxos Scope, designed for retinal imaging and diagnostic evaluation of the eye’s interior structures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Digisight Technologies, Inc. manufacture?
Digisight Technologies, Inc. specializes in ophthalmic fundus cameras, such as the Paxos Scope. These devices are primarily used for capturing detailed images of the retina and other interior structures of the eye, aiding in diagnostic evaluations for eye health.
Where is Digisight Technologies, Inc. based?
Digisight Technologies, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries or databases list Digisight Technologies, Inc.’s devices?
Digisight Technologies, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, safety, and market surveillance purposes.
How are Digisight Technologies, Inc.’s devices classified under FDA regulations?
Digisight Technologies, Inc.’s ophthalmic fundus cameras, such as the Paxos Scope, are classified as Class II devices under FDA regulations. This classification is based on the level of risk associated with the device, requiring special controls in addition to general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- digisight.net
- —
- —
- [email protected]
- Phone
- 1-415-747-7086
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 090751433
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paxos Scope | 40806 | FDA UDI | Class II | Active |
| Paxos Scope | 41177 | FDA UDI | Class II | Active |
| Paxos Scope | 40807 | FDA UDI | Class II | Active |
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