FDA device listing
Hologic Dimensions 3D Mammo
FDA device listing 1533599453 · Block Imaging SAS
Key facts
| Proprietary names | Hologic Dimensions 3D Mammo |
|---|---|
| Owner/operator | Block Imaging SAS |
| Owner/operator number | 10086857 |
| Premarket submissions | P080003 |
| Product codes | OTE |
| Device names | OTE - Digital Breast Tomosynthesis |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OTE |
| Review panels | Radiology |
| Registered establishments | BLOCK IMAGING SAS |
| Establishment registrations | 3023003446 |
| FEI numbers | 3023003446 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database