Second Look Computer-Aided Detection System for Mammography
FDA PMAClass II (US FDA PMA)
by Icad, Inc.
Identity
- Trade Name
- SECOND LOOK (TM) FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P010034 FDA PMA
- FDA Product Code
- MYN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.2070 FDA PMA
- Regulation Number
- 892.2070 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Second Look Computer-Aided Detection System for Mammography is a medical image analyzer designed to assist radiologists in identifying and marking regions of interest on standard mammographic views. It functions as a secondary review tool to highlight areas on mammograms that may require further examination, thereby helping to minimize observational oversights during the initial reading process.
This system is intended for use in radiology settings and operates as a non-sterile, reusable software-based tool integrated with mammography equipment. It does not require specific storage conditions beyond standard IT infrastructure and is classified under FDA’s Premarket Approval (PMA) pathway (PMA Number: P010034). The device adheres to regulatory standards outlined in 21 CFR 892.2070 and is categorized under product code MYN for medical image analyzers.
Frequently asked questions
What is the primary purpose of the Second Look Computer-Aided Detection System for Mammography, and how does it assist radiologists in their workflow?
The Second Look system is designed to act as a secondary review tool for radiologists, helping them identify and mark regions of interest on standard mammographic images after the initial reading. By highlighting areas that may have been overlooked during the first review, it aids in minimizing observational errors and ensures potentially concerning regions are flagged for further examination, thereby improving diagnostic accuracy.
Is the Second Look system a standalone device, or does it require integration with existing mammography equipment?
The Second Look system is a software-based tool that is intended to be integrated with mammography equipment. It functions as a secondary review tool on top of standard mammographic views, meaning it relies on the existing imaging infrastructure to operate effectively.
How is the Second Look system classified in terms of reuse and sterility, and what storage requirements does it have?
The Second Look system is classified as a non-sterile, reusable software-based tool. Since it is software, it does not require specialized storage conditions beyond standard IT infrastructure, such as appropriate server environments or compatible workstations in radiology settings.
What regulatory pathway was followed for the approval of the Second Look system, and what does this imply for its use in clinical settings?
The Second Look system was approved through the FDA’s Premarket Approval (PMA) pathway, indicated by PMA Number P010034. This pathway is typically used for higher-risk devices, ensuring rigorous evaluation of safety and effectiveness before clinical use. Clinically, this means the system has undergone thorough review by the FDA to confirm its intended purpose: assisting radiologists in identifying regions of interest on mammograms to reduce oversight errors.
Are there multiple versions or models of the Second Look system, and if so, how can I identify the correct one for my facility?
The Second Look system appears to be available in multiple configurations, as evidenced by the diverse FEI numbers listed (e.g., 3017840913, 3024891354, etc.). These likely correspond to different software versions, hardware integrations, or system updates. To ensure compatibility, you should verify the specific FEI number or model details with the manufacturer, Icad, Inc., and confirm it aligns with your facility’s existing mammography equipment and IT infrastructure.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P010034 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA PMA P010034 24 fields · synced Sep 18, 2026