510(k) K230906

Konicaminolta DI-X1 by Konica Minolta, Inc. — Product Code LLZ

K230906 is an FDA 510(k) premarket notification submitted by Konica Minolta, Inc. for the device "Konicaminolta DI-X1". The FDA issued a decision of Substantially Equivalent on April 25, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Konica Minolta, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2023
Date Received
March 31, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type