Cleared Traditional

Synaptive ImageDrive Pro

K153284 · Synaptive Medical, Inc. · Radiology
Mar 2016
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K153284 is an FDA 510(k) clearance for the Synaptive ImageDrive Pro, 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 29, 2016, 138 days after receiving the submission on November 12, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K153284 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2015
Decision Date March 29, 2016
Days to Decision 138 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