Cleared Traditional

Optimized Positioning System (OPS) ReView

K193042 · Corin USA · Radiology
Jun 2020
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K193042 is an FDA 510(k) clearance for the Optimized Positioning System (OPS) ReView, 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 June 26, 2020, 239 days after receiving the submission on October 31, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K193042 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2019
Decision Date June 26, 2020
Days to Decision 239 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