Spectralmd, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Spectralmd, Inc. makes
Spectralmd, Inc. manufactures AI-powered imaging systems for wound assessment, including the DeepView AI® System for advanced wound analysis and the SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 for enhanced visual documentation. The company also produces portable physiological imaging devices, such as the DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM, designed for real-time monitoring and evaluation of wound sites.
The company’s portfolio is regulated under FDA Class II devices and includes products listed via the 510(k) clearance pathway. These devices are intended for use in the United States, where Spectralmd, Inc. is based.
Catalogue
- Registry: GUDID
DeepView AI® System Ref DEN250028
Regimes: De Novo Registry: De NovoSpectralmd Deepview Wound Imaging System 2.0 Ref K163339
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectralmd, Inc. have in the registry?
The registry currently lists 4 devices for Spectralmd, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectralmd, Inc.'s devices?
Among its 4 most recently registered devices, Spectralmd, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Spectralmd, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Spectralmd, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectralmd, Inc. in the registry?
The most recently registered devices listed for Spectralmd, Inc. include Spectral AI DeepView AI System, DeepView AI® System, SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 and DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM.