Cleared Traditional

SurgicalAR

K190764 · Medivis, Inc. · Radiology
May 2019
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K190764 is an FDA 510(k) clearance for the SurgicalAR, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Medivis, Inc. (Brooklyn, US). The FDA issued a Cleared decision on May 13, 2019, 49 days after receiving the submission on March 25, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K190764 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2019
Decision Date May 13, 2019
Days to Decision 49 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