PowerLook Tomo Detection Software
FDA PMAClass II (US FDA PMA)
by Icad, Inc.
Identity
- Trade Name
- PowerLook® Tomo Detection Software FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P160009 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 PowerLook Tomo Detection Software is a computer-assisted detection (CAD) device classified as a medical image analyzer. It is designed to assist radiologists in identifying up to five soft tissue densities—including masses, architectural distortions, and asymmetries—within digital breast tomosynthesis (DBT) images. By blending detections with standard 2D synthetic images, the software enhances visualization for review on a mammography workstation, aiding in the identification of potential abnormalities for further evaluation.
This software is intended for concurrent use with GE Senoclaire breast tomosynthesis exams and operates as a Class II medical device under FDA regulation (PMA P160009). It is not a single-use or reusable consumable but rather a standalone analytical tool integrated into radiology workflows. No sterility or MRI safety considerations apply, as it functions as a software-based solution. The device is supplied as a licensed program and requires compatibility with approved mammography review workstations.
Frequently asked questions
What specific types of abnormalities does the PowerLook® Tomo Detection Software help radiologists identify in digital breast tomosynthesis (DBT) images?
The PowerLook® Tomo Detection Software is designed to assist radiologists in identifying up to five types of soft tissue densities within DBT images, including masses, architectural distortions, and asymmetries. These detections are then blended with standard 2D synthetic images to enhance visualization on a mammography workstation, aiding in the potential recognition of abnormalities that may require further evaluation.
Is the PowerLook® Tomo Detection Software compatible with all mammography review workstations, or are there specific requirements for use?
The PowerLook® Tomo Detection Software is a licensed program that requires compatibility with approved mammography review workstations. While it is specifically intended for concurrent use with GE Senoclaire breast tomosynthesis exams, it must be integrated into a radiology workflow that supports its software-based functionality. Compatibility details should be verified with the manufacturer to ensure proper integration.
How is the PowerLook® Tomo Detection Software supplied, and is it considered a single-use or reusable device?
The PowerLook® Tomo Detection Software is supplied as a licensed program, not as a physical consumable or reusable device. Since it operates as a standalone analytical tool, it is not designed for single-use or reuse in the traditional sense. Instead, it is intended for continuous use within radiology workflows, provided the system remains compatible with the approved mammography review workstations.
Does the PowerLook® Tomo Detection Software require any special handling, such as sterility or MRI safety considerations?
No, the PowerLook® Tomo Detection Software does not require sterility or MRI safety considerations. As a software-based solution, it operates independently of physical hardware that would necessitate such precautions. Its use is confined to digital image analysis on compatible mammography workstations, eliminating any need for sterile processing or MRI-related safety measures.
What regulatory pathway was followed for the approval of the PowerLook® Tomo Detection Software, and what does this mean for its use in clinical settings?
The PowerLook® Tomo Detection Software was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA P160009. This classification as a Class II medical device means it has undergone rigorous review to ensure its safety and effectiveness as a computer-assisted detection tool for analyzing DBT images. Clinically, this approval indicates that the software is intended for use by radiologists to assist in identifying potential abnormalities in GE Senoclaire breast tomosynthesis exams, but it does not replace professional judgment.
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 | P160009 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA PMA P160009 24 fields · synced Sep 18, 2026