Certifications

USA

MELODY, Remote Controlled System for Ultrasound Probe is U.S. FDA Cleared

MELODY is indicated for pelvic, abdominal and vascular organs (see tables)

• FDA Approval Letter / K161354
• Indications for Use
• 510(k) Summary (21 CFR 807.92)

Europe

The robotized tele-echography system MELODY was awarded CE Medical Certification in December 2012.

• CE certification is mandatory in Europe and is recognized worldwide.
• This confirms that MELODY is compatible with existing electrical & electromagnetic norms.
• Manufacturing Quality Certification: The full industrial cycle is ISO 9001 & ISO 13485.