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Digital Breast Tomosynthesis
FDA product code OTE · Class 3 · Unknown
88
Registered devices
975
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
3Dimensions — Hologic, Inc.3Dimensions — Hologic, Inc.3Dimensions — Hologic, Inc.Selenia® Dimensions® — Hologic, Inc.not applicable — GE MEDICAL SYSTEMS3Dimensions — Hologic, Inc.Envision — Hologic, Inc.Not Applicable — GE MEDICAL SYSTEMSnot applicable — GE MEDICAL SYSTEMSASPIRE Cristalle Digital Breast Tomosynthesis Option — FUJIFILM CORPORATIONEnvision — Hologic, Inc.Selenia® Dimensions® — Hologic, Inc.3Dimensions™ — Hologic, Inc.Envision — Hologic, Inc.Selenia® Dimensions® — Hologic, Inc.Envision — Hologic, Inc.Selenia® Dimensions® — Hologic, Inc.Senographe Pristina 3D — GE MEDICAL SYSTEMS3Dimensions — Hologic, Inc.not applicable — GE MEDICAL SYSTEMS3Dimensions — Hologic, Inc.Envision — Hologic, Inc.3DQuorum — Hologic, Inc.Selenia Dimensions — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-08 | Hologic, Inc | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| 2025-06-11 | FUJIFILM Healthcare Americas Corporation | Devices had an unapproved slabbing software function enabled for use. |
| 2024-08-19 | Hologic Inc | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of t |
| 2023-01-16 | Hologic, Inc. | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| 2016-02-12 | Siemens Medical Solutions USA, Inc | A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast |
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