| Primary Device ID | 00858012005793 |
| NIH Device Record Key | aa3de529-9f2a-4c24-b775-2d6e773c417f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerlook PRO Hardware Upgrade, SLD |
| Version Model Number | V7.2 |
| Catalog Number | DSC017-02-US |
| 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 |
| Phone | 866-280-2239 |
| support@icadmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858012005793 [Primary] |
| MYN | Analyzer,Medical Image |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-03 |
| 00858012005793 | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and |
| 00858012005823 | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and |
| 00858012005809 | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and |