Cleared Special

ImagePilot

K210066 · Konica Minolta, Inc. · Radiology
May 2021
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K210066 is an FDA 510(k) clearance for the ImagePilot, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on May 6, 2021, 115 days after receiving the submission on January 11, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K210066 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2021
Decision Date May 06, 2021
Days to Decision 115 days
Submission Type Special
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