Cleared Traditional

SuRgical Planner (SRP) BrainStorm

K201465 · Surgical Theater, Inc. · Radiology
Jul 2020
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K201465 is an FDA 510(k) clearance for the SuRgical Planner (SRP) BrainStorm, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Surgical Theater, Inc. (Mayfield Village, US). The FDA issued a Cleared decision on July 17, 2020, 45 days after receiving the submission on June 2, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K201465 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2020
Decision Date July 17, 2020
Days to Decision 45 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