Identity
- Trade Name
- SECOND LOOK FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P010038 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
- APRL FDA PMA
The SecondLook (SL) CAD is a medical image analyzer system intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed. This system assists radiologists in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.
The device is supplied as a computer system and is regulated under FDA PMA authorization. It is designed for use in radiology settings and is intended for single-use applications. The system is not specified as MRI compatible and should be stored according to the manufacturer's instructions. The device is authorized for use as a computer-assisted detection system to support mammography interpretation.
Frequently asked questions
What is the purpose of the SecondLook CAD system?
The SecondLook CAD system is designed to identify and mark regions of interest on standard mammographic views after the initial reading, helping radiologists minimize observational oversights by highlighting areas that may warrant a second review.
How is the SecondLook CAD system supplied?
The device is supplied as a computer system and is intended for single-use applications in radiology settings, requiring storage according to the manufacturer's instructions.
What regulatory authorization does the SecondLook CAD system have?
The SecondLook CAD system is authorized under FDA PMA (Premarket Approval) with the PMA number P010038, indicating it has received approval as a computer-assisted detection system to support mammography interpretation.
Is the SecondLook CAD system MRI compatible?
The device data does not specify MRI compatibility, so it should not be assumed to be compatible with MRI environments without further clarification from the manufacturer.
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 | P010038 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA PMA P010038 24 fields · synced Sep 18, 2026