INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
FDA premarket approval P110006/S004 · decided 2014-11-24
Approval details
- PMA number
- P110006
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2014-11-03
- Decision date
- 2014-11-24
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- APPROVAL OF A CHANGE IN THE DEVICE DESIGN TO ACCOMMODATE A NEW DEVICE CONFIGURATION. THE NEW DEVICE CONFIGURATION CONSISTS OF THE FOLLOWING COMPONENTS: INVENIA ABUS SCAN STATION, INVENIA ABUS REVIEW SOFTWARE, AND USER COMPUTER/ WORK STATION THAT IS QUALIFIED TO MEET A REQUIRED SET OF HARDWARE AND SOFTWARE SPECIFICATION. IN ADDITION TO THE PROPOSED ADDITIONAL DEVICE CONFIGURATION, YOUR SUPPLEMENT REQUESTED APPROVAL OF MINOR SOFTWARE UPDATES TO ADDRESS ISSUES DISCOVERED THROUGH INTERNAL TESTING AN
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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 |