{"product_id":"fda-510k-k250367","title":"FDA 510(k) K250367, CoLumboX, by Smart Soft Healthcare AD","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAutomated Radiological Image Processing Software\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK250367\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e CoLumboX\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Smart Soft Healthcare AD\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e892.2050\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQIH\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e02\/10\/2025\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 05\/28\/2025\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eRadiology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eRadiology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 647\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 409\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 238\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313337925796,"sku":"FDA510K250367","price":759.4,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k250367","provider":"FOIA Document Source","version":"1.0","type":"link"}