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SecondLook (SL) CAD

by Icad, Inc.

PMA P010038

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P010038↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP010038 Date15 Jan 2002DecidedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Second Look
Generic name
Analyzer, medical image
PMA number
FDA product code
MYN
Device class
Class II
Regulation
21 CFR Part 892.2070
Advisory committee
Radiology
FDA decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under P010038

27 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under P010038
UDI-DISize and differences
PowerLook AMP PRO with SecondLook Digital V7.2
Icad, Inc.
DSC017-01-US / V7.200858012005601
Prescription: yes
On the market
PowerLook AMP PRO, SLD, GE, ROW V7.2
Icad, Inc.
DSC017-01-ROW / V7.200858012005830
Prescription: yes
On the market
PowerLook AMP PRO, SLD, GE, ROW V7.2
Icad, Inc.
DSC017-04-ROW / V7.200858012005847
Prescription: yes
On the market
PowerLook AMP SLD Agfa CR DSC010-09
Icad, Inc.
DSC010-0900858012005175
Prescription: no
On the market
PowerLook AMP SLD FRU GE V7.2
Icad, Inc.
2376858-8-US / V7.200858012005083
Prescription: yes
On the market
PowerLook AMP SLD FRU V7.2
Icad, Inc.
D4D0147 / V7.200858012005076
Prescription: yes
On the market
PowerLook AMP SLD Fuji OUS DSC010-04-EU
Icad, Inc.
DSC010-04-EU00858012005120
Prescription: no
On the market
PowerLook AMP SLD Fuji V7.2
Icad, Inc.
DSC010-04-US / V7.200858012005045
Prescription: yes
On the market
PowerLook AMP SLD GE Direct V7.2
Icad, Inc.
DSC010-12-US / V7.200858012005021
Prescription: yes
On the market
PowerLook AMP SLD GE OUS Direct DSC010-12-EU
Icad, Inc.
DSC010-12-EU00858012005106
Prescription: no
On the market
PowerLook AMP SLD GE OUS DSC010-01-EU
Icad, Inc.
DSC010-01-EU00858012005090
Prescription: no
On the market
PowerLook AMP SLD GE US V7.2
Icad, Inc.
DSC010-01-US / V7.200858012005014
Prescription: yes
On the market
PowerLook AMP SLD Giotto DSC010-06
Icad, Inc.
DSC010-0600858012005144
Prescription: no
On the market
PowerLook AMP SLD Hologic OUS DSC010-05-EU
Icad, Inc.
DSC010-05-EU00858012005137
Prescription: no
On the market
PowerLook AMP SLD Hologic V7.2
Icad, Inc.
DSC010-05-US / V7.200858012005052
Prescription: yes
On the market
PowerLook AMP SLD Philips OUS DSC010-07-EU
Icad, Inc.
DSC010-07-EU00858012005151
Prescription: no
On the market
PowerLook AMP SLD Philips V7.2
Icad, Inc.
DSC010-07-US / V7.200858012005069
Prescription: yes
On the market
PowerLook AMP SLD Planmed DSC010-08
Icad, Inc.
DSC010-0800858012005168
Prescription: no
On the market
PowerLook AMP SLD Siemens OUS DSC010-03-EU
Icad, Inc.
DSC010-03-EU00858012005113
Prescription: no
On the market
PowerLook AMP SLD Siemens V7.2
Icad, Inc.
DSC010-03-US / V7.200858012005038
Prescription: yes
On the market
Powerlook PRO Hardware Upgrade, SLD V7.2
Icad, Inc.
DSC017-02-ROW / V7.200858012005809
Prescription: yes
On the market
Powerlook PRO Hardware Upgrade, SLD V7.2
Icad, Inc.
DSC017-02-US / V7.200858012005793
Prescription: yes
On the market
Powerlook PRO Hardware Upgrade, SLD V7.2
Icad, Inc.
DSC017-03-ROW / V7.200858012005823
Prescription: yes
On the market
Powerlook PRO with SLD, FRU V7.2
Icad, Inc.
D4D0192 / V7.200858012005861
Prescription: yes
On the market
Powerlook PRO with SLD, GE, US V7.2
Icad, Inc.
DSC017-04-US / V7.200858012005854
Prescription: yes
On the market
PowerLook to PowerLook PRO Upgrade, US V7.2
Icad, Inc.
DSC017-03-US / V7.200858012005816
Prescription: yes
On the market
SecondLook Digital (SLD) V7.2
Icad, Inc.
DS0206 / V7.200858012005007
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code MYN (Analyzer, Medical Image).

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