SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
FDA premarket approval P110006/S001 · decided 2013-06-17
Approval details
- PMA number
- P110006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2013-03-07
- Decision date
- 2013-06-17
- Days to decision
- 102 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- APPROVAL FOR A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST I
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510(k) clearances by this applicant
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| View (K253639) | GE Healthcare | 2026-01-08 |
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| 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 |