PowerLook AMP PRO, SLD, GE, ROW DSC017-01-ROW

GUDID 00858012005830

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Icad, Inc.

Basic diagnostic x-ray system application software

• Primary Device ID: 00858012005830
• NIH Device Record Key: 18f04b31-dae6-4911-afaf-6b194ae5e5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerLook AMP PRO, SLD, GE, ROW
• Version Model Number: V7.2
• Catalog Number: DSC017-01-ROW
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com
• Phone: 866-280-2239
• Email: support@icadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010038

FDA Product Code

• MYN: Analyzer,Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [PowerLook AMP PRO, SLD, GE, ROW]

• 00858012005847: The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and
• 00858012005830: The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and