Product code OTE ยท Class 3
Digital Breast Tomosynthesis
0510(k)s in 12 months (0 all time)
1recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in OTE
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic Inc | 0 | 3 |
| FUJIFILM Healthcare Americas Corporation | 0 | 1 |
| Siemens Medical Solutions USA, Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Hologic, Inc 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-N Open, Classified |
OTE | None listed |
| Jul 30, 2025 | FUJIFILM Healthcare Americas Corporation ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). Open, Classified |
OTE | None listed |
| Sep 25, 2024 | Hologic Inc Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis
Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows
Model/Catalog Number:
1. ASY-16824 FMI UPGRADE KIT, DIM Open, Classified |
OTE | None listed |
| Feb 21, 2023 | Hologic, Inc. Hologic 3Dimensions/Selenia Dimensions
Models:
RM-SDM-00001-3D
SDM-00001-2D
SDM-00001-3D
SDM-05000-3D3
SDM-05000-2DC
SDM-00001-M3D
SDM-05000-3DC
SDM-SYS-6000-3D
SDM-05000-2D3
SDA-SYS-3000-2D
SDM-0000 Open, Classified |
OTE | None listed |
| Feb 12, 2016 | Siemens Medical Solutions USA, Inc Mammomat Inspiration with Tomosynthesis functionality Terminated |
OTE | None listed |
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