510(k) K240281

Bone Suppression Software by Konica Minolta, Inc. — Product Code LLZ

K240281 is an FDA 510(k) premarket notification submitted by Konica Minolta, Inc. for the device "Bone Suppression Software". The FDA issued a decision of Substantially Equivalent on May 31, 2024. 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
May 31, 2024
Date Received
February 1, 2024
Clearance Type
Traditional
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