Cleared Special

KONICAMINOLTA DI-X1

K212685 · Konica Minolta, Inc. · Radiology

Sep 2021

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K212685 is an FDA 510(k) clearance for the KONICAMINOLTA DI-X1, 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 September 13, 2021, 20 days after receiving the submission on August 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K212685 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2021
Decision Date	September 13, 2021
Days to Decision	20 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF