Cleared Traditional

Optimized Positioning System (OPS) Insight

K202805 · Corin USA · Radiology
Nov 2020
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K202805 is an FDA 510(k) clearance for the Optimized Positioning System (OPS) Insight, 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 20, 2020, 58 days after receiving the submission on September 23, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K202805 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2020
Decision Date November 20, 2020
Days to Decision 58 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