INVENIA ABUS
FDA premarket approval P110006/S003 · decided 2014-03-20
Approval details
- PMA number
- P110006
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INVENIA ABUS
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2014-02-26
- Decision date
- 2014-03-20
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- CHANGES TO INCLUDE UPDATING MANUFACTURING DOCUMENTS, WORK INSTRUCTIONS, AND TEST PROCEDURES. ALSO, HIGH LEVEL ASSEMBLY OF SOME SUBCOMPONENTS WILL BE PERFORMED BY PLEXUS CORPORATION.
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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 |