Konica Minolta, Inc.
FDA Regulatory Profile
Konica Minolta, Inc. appears in FDA public data with 1 recall, 25 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2769-2017, Class II) was initiated on Apr 24, 2017. Its most recent 510(k) clearance was granted on Jun 17, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 25
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2769-2017 | Class II | Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 | Apr 24, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250665 | SKR 3000 | Jun 17, 2025 |
| K241319 | SKR 3000 | Nov 21, 2024 |
| K240281 | Bone Suppression Software | May 31, 2024 |
| K230906 | Konicaminolta DI-X1 | Apr 25, 2023 |
| K223267 | SKR 3000 | Nov 17, 2022 |
| K220993 | Ultrasound System SONIMAGE MX1 | Jun 23, 2022 |
| K213908 | SKR 3000 | Jan 31, 2022 |
| K212685 | KONICAMINOLTA DI-X1 | Sep 13, 2021 |
| K210619 | SKR 3000 | Aug 24, 2021 |
| K210066 | ImagePilot | May 6, 2021 |
| K191645 | SKR 4000 | Aug 16, 2019 |
| K182688 | SKR 3000 | Dec 18, 2018 |
| K182431 | Konicaminolta DI-X1 | Nov 26, 2018 |
| K182153 | Ultrasound System SONIMAGE HS1 | Sep 6, 2018 |
| K180084 | Ultrasound System SONIMAGE MX1 | Feb 8, 2018 |
| K172793 | SKR 3000 | Oct 12, 2017 |
| K171716 | SKR 3000 | Aug 25, 2017 |
| K162065 | Ultrasound System SONIMAGE HS1 | Oct 19, 2016 |
| K162504 | SKR 3000 | Oct 3, 2016 |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | Oct 8, 2015 |