Cleared Traditional

Konicaminolta DI-X1

K182431 · Konica Minolta, Inc. · Radiology

Nov 2018

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K182431 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 November 26, 2018, 81 days after receiving the submission on September 6, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K182431 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2018
Decision Date	November 26, 2018
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement