Konica Minolta, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
25
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2769-2017Class IIDiagnostics Ultrasound System Ultrasounds System Sonimage HS1April 24, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K250665SKR 3000June 17, 2025
K241319SKR 3000November 21, 2024
K240281Bone Suppression SoftwareMay 31, 2024
K230906Konicaminolta DI-X1April 25, 2023
K223267SKR 3000November 17, 2022
K220993Ultrasound System SONIMAGE MX1June 23, 2022
K213908SKR 3000January 31, 2022
K212685KONICAMINOLTA DI-X1September 13, 2021
K210619SKR 3000August 24, 2021
K210066ImagePilotMay 6, 2021
K191645SKR 4000August 16, 2019
K182688SKR 3000December 18, 2018
K182431Konicaminolta DI-X1November 26, 2018
K182153Ultrasound System SONIMAGE HS1September 6, 2018
K180084Ultrasound System SONIMAGE MX1February 8, 2018
K172793SKR 3000October 12, 2017
K171716SKR 3000August 25, 2017
K162065Ultrasound System SONIMAGE HS1October 19, 2016
K162504SKR 3000October 3, 2016
K152577ULTRASOUND SYSTEM SONIMAGE HS 1October 8, 2015