PMA
P160031: ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
FDA PMA · Digital breast tomosynthesis · Fujifilm Medical Systems U.S.A, Inc.
Key facts
| PMA number | P160031 |
|---|---|
| Trade name | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION |
| Generic name | Digital breast tomosynthesis |
| Applicant | Fujifilm Medical Systems U.S.A, Inc. |
| Owner/operator | FUJIFILM CORPORATION |
| Product code | OTE |
| Approval date | Jan 10, 2017 |
| Docket number | 17M-0181 |
| Notice date | Jan 12, 2017 |
| Establishment registration | 3001722928 |
| FEI number | 3001722928 |
At a glance
- 1–9 Supplements
- Feb 13, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: