Cleared Traditional

K200973 - Synapse 3D Cardiac Tools (FDA 510(k) Clearance)

K200973 · Fujifilm Corporaton · Radiology device

Aug 2020

Decision

136d

Days

Class 2

Risk

K200973 is an FDA 510(k) clearance for the Synapse 3D Cardiac Tools. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Fujifilm Corporaton (Tokyo, JP). The FDA issued a Cleared decision on August 27, 2020, 136 days after receiving the submission on April 13, 2020.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K200973 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 13, 2020
Decision Date	August 27, 2020
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF