| Primary Device ID | 00858012005939 |
| NIH Device Record Key | 7b66ec62-b820-4371-b8cd-1844e52eddb8 |
| Commercial Distribution Discontinuation | 2019-07-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PowerLook Tomo Detection (ProFound AI) |
| Version Model Number | V2 |
| 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 | false |
| Manufacturing Date | false |
| 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 | 00858012005939 [Primary] |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-12 |
| Device Publish Date | 2018-12-27 |
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| 00850008977275 - ProFound AI 3.1 | 2024-06-18 |
| 00850008977282 - TESTING | 2024-06-18 |
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| 00850008977305 - PowerLook 10.1.1 | 2024-06-18 |
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