Cleared Traditional

Bone Suppression Software

K240281 · Konica Minolta, Inc. · Radiology

May 2024

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K240281 is an FDA 510(k) clearance for the Bone Suppression Software, 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 May 31, 2024, 120 days after receiving the submission on February 1, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K240281 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2024
Decision Date	May 31, 2024
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF