FDA device listing
AMULET Innovality Digital Breast Tomosynthesis Option,ASPIRE Cristalle Digital Breast Tomosynthesis Option
FDA device listing 1138100001 · FUJIFILM CORPORATION
Key facts
| Proprietary names | AMULET Innovality Digital Breast Tomosynthesis Option,ASPIRE Cristalle Digital Breast Tomosynthesis Option |
|---|---|
| Owner/operator | FUJIFILM CORPORATION |
| Owner/operator number | 8031568 |
| Premarket submissions | P160031 |
| Product codes | OTE |
| Device names | OTE - Digital Breast Tomosynthesis |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OTE |
| Review panels | Radiology |
| Registered establishments | FUJIFILM CORPORATION, FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office |
| Establishment registrations | 3001722928, 3003775006 |
| FEI numbers | 3001722928, 3003775006 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 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