SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P010034/S001 · decided 2002-05-07
Approval details
- PMA number
- P010034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2002-03-04
- Decision date
- 2002-05-07
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR AN OVERALL UPGRADE TO THE HARDWARE AND SOFTWARE IN THE DEVICE. THESE CHANGES IMPROVED THE SENSITIVITY, DECREASED THE MARKS PER CASE AND MADE AN IMPROVEMENT IN FALSE NEGATIVES. IN ADDITION, SOFT-COPY, INCREASED STORAGE, AND DICOM INTERFACING WERE ADDED ALONG WITH SUNDRY OTHER OPERATING IMPROVEMENTS.
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|---|---|---|
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| PowerLook Density Assessment Software (K180125) | Icad, Inc. | 2018-04-05 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |