Cleared Special

Konicaminolta DI-X1

K230906 · Konica Minolta, Inc. · Radiology
Apr 2023
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K230906 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. (Tokyo, JP). The FDA issued a Cleared decision on April 25, 2023, 25 days after receiving the submission on March 31, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K230906 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date April 25, 2023
Days to Decision 25 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