# SecondLook (SL) CAD

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/second-look-p010038>
- Manufacturer: [Icad, Inc.](https://devicerts.com/manufacturers/icad-inc) (United States, FDA PMA applicant)
- Name in the registry: SECONDLOOK (SL) CAD
- Device class: Class II (US FDA)
- FDA product code: MYN

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **PMA** · FDA PMA · United States · P010038 · decision 2002-01-15 · decision APRL · status: Active

## Recalls

No recall on record.

## 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]
- Regulation: 21 CFR Part 892.2070 [FDA PMA]
- Advisory committee: Radiology [FDA PMA]
- FDA decision: APRL [FDA PMA]

## Source and citation

- Cite as: SecondLook (SL) CAD, Icad, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/second-look-p010038 (data as of 2026-11-15).
- Data sources: [FDA PMA](https://open.fda.gov/apis/device/pma/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/second-look-p010038.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/second-look-p010038
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.