Cleared Traditional

Corin Optimized Positioning System (OPS) Plan

K183038 · Corin USA · Radiology
Nov 2018
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K183038 is an FDA 510(k) clearance for the Corin Optimized Positioning System (OPS) Plan, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on November 26, 2018, 25 days after receiving the submission on November 1, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K183038 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2018
Decision Date November 26, 2018
Days to Decision 25 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050