The product, sold in the EU, does not seem to be FDA cleared.
Key features include:
- Real-time display of fluorescence and clinical in special overlay mode.
- Usability under ambient light. Up to 3 live images (full screen, split screen).
- Fluorescence- guided biopsy and diagnosis (investigator-independent).
- Detection of clinical invisible (incipient) lesions.
- Monitoring of therapeutic success, e.g. following surgery, cryotherapy, PDT. Professional data base for documentation. Flexible arm for easy positioning of camera and light source.
- Image spot size: typical 10 cm x 10 cm Filming speed: 33 Hz
Please, couls I see the FDA certificate since in the FDA site there isn't any product with this Name?
ReplyDeleteThank you very much, best regards,
Raffaella Bisson