Telehealth Imaging Solution
Silhouette Home User enables patients to easily and securely take images and record notes on their mobile devices without leaving home. The patient’s assessment information is instantly available for their healthcare provider to review and assess on SilhouetteCentral.
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Silhouette enables healthcare providers to record and store images and assessments for review at a later time.
Healthcare providers can securely share the recorded data when there is an internet connection available. The information can be shared with other specialists via PDF reports or online via the secure SilhouetteCentral database or the organization’s EMR.
Silhouette has the following regulatory approvals:
- FDA cleared – 510(k) number K070426
- Health Canada – Therapeutic Products Directorate
- CE Mark
- TGA approval (Australia)
- WAND registration (New Zealand)
- Singapore regulatory clearance
Silhouette also supports compliance with the Code of Federal Regulations (CFR), 21 CFR Part 11 and HIPAA
ARANZ Medical has ISO 13485:2016 Certification