INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
FDA premarket approval P110006/S006 · decided 2015-10-15
Approval details
- PMA number
- P110006
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2015-09-18
- Decision date
- 2015-10-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY. THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE. THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
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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 |