Cleared Traditional

BrightMatter Plan 1.6.0

K180394 · Synaptive Medical, Inc. · Radiology
Mar 2018
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K180394 is an FDA 510(k) clearance for the BrightMatter Plan 1.6.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on March 9, 2018, 24 days after receiving the submission on February 13, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K180394 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2018
Decision Date March 09, 2018
Days to Decision 24 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