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DS/EN ISO 13485:2016 and EN ISO 13485:2016
The scope of the certificate is:
Design, development, production and servicing of gamma cameras.
Directive 93/42/EEC – Annex II
The scope of the certificate is:
Design, manufacture and final inspection of gamma cameras in class IIa and related accessories in class IIb.
FDA Certificate K140206 May 2014.05.14
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