HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S019 · decided 2010-11-16
Approval details
- PMA number
- P010025
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2010-06-01
- Decision date
- 2010-11-16
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR ADDITIONAL AUTOMATIC EXPOSURE CONTROL (AEC) TECHNIQUE TABLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |