PowerLook Cloud 1.0

GUDID 00085000897751

Icad, Inc.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 00085000897751
• NIH Device Record Key: 3ceb1131-d8d5-4dc9-a995-ad438dcaaaee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerLook Cloud 1.0
• Version Model Number: DSC038-01
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085000897751 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by Icad, Inc.

• 00850008977527 - PowerLook 11.3: 2023-08-10
• 00085000897751 - PowerLook Cloud 1.0: 2023-07-25
• 00085000897751 - PowerLook Cloud 1.0: 2023-07-25
• 00850008977442 - PowerLook 11.2: 2023-07-24
• 00850008977459 - PowerLook Al Mammo Container - Radiology Partners v1.0.0: 2023-07-24
• 00850008977466 - PowerLook Al Mammo Container- GE v1.1.0: 2023-07-24
• 00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0: 2023-07-24
• 00850008977480 - PowerLook Al Mammo Container- Ferrum v1.0.0: 2023-07-24
• 00850008977497 - PowerLook Al Mammo Container - Arterys v 1.2.0: 2023-07-24