INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
FDA premarket approval P110006/S005 · decided 2015-04-13
Approval details
- PMA number
- P110006
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2015-02-27
- Decision date
- 2015-04-13
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS,
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510(k) clearances by this applicant
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| Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642) | GE Healthcare | 2022-01-13 |