# OTE · Digital Breast Tomosynthesis

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/RA-misc/OTE

## Overview

- **Product Code:** OTE
- **Device Name:** Digital Breast Tomosynthesis
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160031](https://fda.innolitics.com/submissions/RA/RA-misc/OTE/P160031.md) | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION | Fujifilm Medical Systems U.S.A, Inc. | Jan 10, 2017 | APPR |
| [P140011](https://fda.innolitics.com/submissions/RA/RA-misc/OTE/P140011.md) | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | Apr 21, 2015 | APPR |
| [P130020](https://fda.innolitics.com/submissions/RA/RA-misc/OTE/P130020.md) | SENOCLAIRE | GE Healthcare | Aug 26, 2014 | APPR |
| [P080003](https://fda.innolitics.com/submissions/RA/RA-misc/OTE/P080003.md) | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | Feb 11, 2011 | APPR |

## Top Applicants

- Fujifilm Medical Systems U.S.A, Inc. — 1 clearance
- GE Healthcare — 1 clearance
- Hologic, Inc. — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/RA-misc/OTE](https://fda.innolitics.com/submissions/RA/RA-misc/OTE)

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