Cleared Traditional

K180394 - BrightMatter Plan 1.6.0 (FDA 510(k) Clearance)

K180394 · Synaptive Medical, Inc. · Radiology device

Mar 2018

Decision

24d

Days

Class 2

Risk

K180394 is an FDA 510(k) clearance for the BrightMatter Plan 1.6.0. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K180394 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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