Invenia ABUS Premium, Invenia ABUS Prime
FDA premarket approval P110006/S011 · decided 2025-02-04
Approval details
- PMA number
- P110006
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Invenia ABUS Premium, Invenia ABUS Prime
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2024-07-15
- Decision date
- 2025-02-04
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for modification of the currently-approved transducer, addition of a new transducer, hardware changes, addition of two new device names, and addition of two new features: Auto Nipple Detection, and Scan Quality Assessment.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| View (K253639) | GE Healthcare | 2026-01-08 |
| MR Contour DL (K242925) | GE Healthcare | 2025-04-01 |
| Digital Expert Access with Remote Scanning (K232346) | GE Healthcare | 2023-10-27 |
| Precision DL (K223212) | GE Healthcare | 2023-04-27 |
| Xeleris V Processing and Review System (K221680) | GE Healthcare | 2023-03-01 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |
| Voluson P6, Voluson P8 (K213689) | GE Healthcare | 2022-02-17 |
| Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642) | GE Healthcare | 2022-01-13 |