{"product_id":"fda-510k-k191713-cs-series-fp-radiographic-fluoroscopic-systems-with-ca-100s-fluoroshield","title":"FDA 510(k) K191713, CS-Series-FP Radiographic\/Fluoroscopic Systems with CA-100S FluoroShield, by Omega Medical Imaging, LLC","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K191713 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e CS-series-FP Radiographic \/ Fluoroscopic Systems with Optional CA-100S \/ FluoroShield™ (ROI Assembly) \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Omega Medical Imaging, LLC\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, x-ray, fluoroscopic, image-intensified \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1650 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e JAA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/26\/2019 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/04\/2019 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cstrong data-start=\"57\" data-end=\"73\"\u003eTotal pages:\u003c\/strong\u003e 1,291\u003cbr data-start=\"79\" data-end=\"82\"\u003e\u003cstrong data-start=\"82\" data-end=\"107\"\u003eFully redacted pages:\u003c\/strong\u003e 1,091\u003cbr data-start=\"113\" data-end=\"116\"\u003e\u003cstrong data-start=\"116\" data-end=\"134\"\u003eContent pages:\u003c\/strong\u003e 200\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429478596772,"sku":"FDA510K191713","price":521.56,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k191713-cs-series-fp-radiographic-fluoroscopic-systems-with-ca-100s-fluoroshield","provider":"FOIA Document Source","version":"1.0","type":"link"}