ProFound AI
GUDID 00858012005960
Icad, Inc.
Basic diagnostic x-ray system application software| Primary Device ID | 00858012005960 |
| NIH Device Record Key | e2d54c17-2ff2-40b7-ba52-ca52ce593384 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProFound AI |
| Version Model Number | 2.1 |
| 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 |
Customer Support Contacts
| Phone | (866) 280-2239 |
| Support@icadmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858012005960 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182373
FDA Product Code
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
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 | 2019-07-19 |
| Device Publish Date | 2019-07-11 |
Devices Manufactured by Icad, Inc.
Trademark Results [ProFound AI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFOUND AI 88188301 not registered Live/Pending |
iCad, Inc. 2018-11-09 |
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