Cleared Traditional

Synapse 3D Base Tools v6.6

K221677 · Fujifilm Corporation · Radiology
Nov 2022
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K221677 is an FDA 510(k) clearance for the Synapse 3D Base Tools v6.6, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on November 10, 2022, 154 days after receiving the submission on June 9, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K221677 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2022
Decision Date November 10, 2022
Days to Decision 154 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