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Equivalence Letter C-Arm
Equivalence Letter C-Arm
We, A.T.S. Applicazione Tecnologie Speciali s.r.l., with facilities at Via A. Volta 10, 24060, Torre dè Roveri,
Bergamo, Italy, hereby declare that:
• We are manufacturers of X-ray Equipments which we authorize to be sold by the company FUJIFILM,
under their own brand and model names:
• All electrical tests, emission, security, IEC, quality or any other test performed by A.T.S. or A.T.S.’s
Notifying Body , including labels, manuals and brochures of the above-mentioned X-ray Equipments
will also be valid for the systems supplied by FUJIFILM
• All tests were performed in the digital units with maximum power, as they are the worst-case
scenario from EMC and Electrical Safety point of view. Hence, all the documents referenced in the
essential requirements for the A.T.S.’s ARCO FP / ARCO FP-S units are also valid for the FUJIFILM’s
Persona units.
Yours sincerely,
Livia Pillitteri
QMS & Regulatory Affairs Manager
A.T.S. Applicazione Tecnologie Speciali s.r.l.
VIA A. VOLTA, 10 – 24060 TORRE DE’ ROVERI (BG) ITALY – TEL. +39.035.584311 – FAX +39.035.580220 – E-mail: sales@atsmed.it
Cap. Soc. € 63300 i.v. Società con socio unico – R.E.A. BG 257164 – REGISTRO IMPRESE C. F. e P. IVA 02037400161
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