Konica Minolta Healthcare Americas, Inc.
Konica Minolta Healthcare Americas, Inc. appears in FDA public data with 1 recall, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0500-2022, Class II) was initiated on December 3, 2021. Its most recent 510(k) clearance was granted on June 12, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Known Names
konica minolta healthcare americas, konica minolta healthcare, americas
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0500-2022 | Class II | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medi | December 3, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252996 | Universal 1417PI | June 12, 2026 |
| K221853 | OTC DDR | July 27, 2022 |
| K214030 | Universal DR 1748 | January 21, 2022 |
| K214012 | Straight Arm DDR | January 12, 2022 |
| K203743 | EXA | December 10, 2021 |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with | January 15, 2020 |