| Primary Device ID | 00858012005908 |
| NIH Device Record Key | 4d7f83dd-75dc-4bcc-8521-267b9b5352d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VeraLook CTC CAD |
| Version Model Number | V1.0 |
| Catalog Number | CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70 |
| 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 | 1-866-280-2239 |
| service@icadmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858012005908 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| 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 | 2018-02-08 |
| 00858012005908 | VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra |
| 00858012005915 | VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra |
| 00858012005892 | VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra |
| 00858012005885 | VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra |