Identity
- Trade Name
- PowerLook AMP SLD FRU FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- 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. Field Replacement System FDA UDI
- Model / Reference
- V7.2 FDA UDI
- Description
- 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. Field Replacement System FDA UDI
Identifiers
- Catalog Number
- D4D0147 FDA UDI
- Primary DI / UDI-DI
- 00858012005076 FDA UDI
- PMA Number
- P010038 FDA UDI
- FDA Product Code
- MYN FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic diagnostic x-ray system application software
PowerLook AMP SLD FRU by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P010038 also covers:
- PowerLook AMP PRO with SecondLook Digital — Icad, Inc.
- PowerLook AMP PRO, SLD, GE, ROW — Icad, Inc.
- PowerLook AMP PRO, SLD, GE, ROW — Icad, Inc.
- PowerLook AMP SLD Agfa CR — Icad, Inc.
- PowerLook AMP SLD FRU GE — Icad, Inc.
- PowerLook AMP SLD Fuji — Icad, Inc.
- PowerLook AMP SLD Fuji OUS — Icad, Inc.
- PowerLook AMP SLD GE Direct — Icad, Inc.
- PowerLook AMP SLD GE OUS — Icad, Inc.
- PowerLook AMP SLD GE OUS Direct — Icad, Inc.
- PowerLook AMP SLD GE US — Icad, Inc.
- PowerLook AMP SLD Giotto — Icad, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA UDI cee1996c-711a-49a0-b67b-4b3e98b60afb 35 fields · synced May 31, 2026