FEDERAL (GENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP) & FREE DE CERTIFICATE OF A MEDICAL DEVICE 1914-06-14 ig) country: Belgium ietnam SECTION TO BE COMPLETED BY THE APPLICANT OF THE CERTIFICATE 1. Name and form of product: Digitizer 1.1. Classification according to Council Directive 93/42/EEC: Na 1.2. Qualitative and quantitative composition or description (according to the type of the device): - CR 15-X: The CR 15-X is part of a CR system, further containing a cassette, image plate and modality workstation. ‘The CR system is used in’a radiological environment by qualified staff to read-out, process and route static Xray racigpraphic mages. The cassette 's used to protect the image piate from light and damages during X-ray exposure, transport and handling. ‘the image plate is used to capture the static X-ray radiographic images; the image plate is scanned by the digitizer. The CR 15-X digitizer is used to scan an X-ray exposed image plate, it results into a digital image which is sent to the dedicated workstation. The modality workstation is used to process arid route the digital images from the digitizer. 1.3. |s this product authorized to be placed on the market for use in the exporting country? YES 1.4. |s this product actually on the market in the exporting country? YES 1.5. Does the exported product carry the CE mark according directive EEC/93/42? YES 2. Information regarding the manufacturer: 2.1. Manufacturer (according to the definition of Council Dirgctive 93/42/EEC): AGFA HEALTHCARE N.V., Septestraat 27, B-2640 Mortsel, Belgium 2.2. Production site: Agfa-Gevaert HealthCare GmbH, Max-Planck-Str.1, D-82380 PeiBenberg, Germany. 3 ; 2.3, Applicant for certificate: Koen Vervoort, AGFA HEALTHCARE N.V., Septestraat 27, B-2640 Mortsol, Belgium ~ 2.4, Name and number of the Notified Body (if applicable): Intertek Semko AB, id number 0413 (see annexes) 3. Has the production facility been certified to be in compliance with ISO 9000 / ISO 13485 standards? YES If yes state the name of the organisation that delivered the certificate: Intertek Semko AB If no, please explain: RESERVED FOR THE ADMINISTRATION The medical device as described above is presumed to meet the applicable provisions of Council Directive 93/42/EEC and can be placed on the market in the exporting country. ‘Victor Hortaplein 40 bus 40, 1060 BRUSSELS (BELGIUM) Telephone n°: +32 2 24.80.00 Fax n°: +32 2624.81.20 pee 14 AVR. 2016 Stamp: Name of authorized person: gee Xavier De Cuyper @ | “iat Execute Oncar eo (PP Vanessa BINAME “Agence Feral de Méceaments ‘tes Pots gesonteer | 4s J oudw chew VET eM rat oN Oude of AGACSADE DE LA RS. OU VIET NAMM ‘AUPRES ROYAUIE DE BELGIQUE ‘CHUNG MANIAC PHP HOA LAN Sy avanti corade ae ‘vera Sips tuny 2.00690 (68) gleam. Va ‘cede aN fe ew Mean, isting Me! : sy ‘ee / rcenngrrofrgns hy ‘sen en Te sate a 1.Goqn On a an Vita 1 iietotyerionentosae de a signee des tie van de antekening van ‘Geschen zur Legation der Untese if on! 28/04/2014 Brussel/Bruxelles/Brisse! Binamé, Vanessa Ne 9805140428500320 Cate gas ollie va se Di eyanaion eet J Doves er eh des als es Dok Jan Vande Velde