The following data is part of a premarket notification filed by Iterative Scopes Inc. with the FDA for Skout Software.
| Device ID | K213686 |
| 510k Number | K213686 |
| Device Name: | SKOUT Software |
| Classification | Gastrointesinal Lesion Software Detection System |
| Applicant | Iterative Scopes Inc. 14 Arrow St, 3rd Floor Cambridge, MA 02138 |
| Contact | Daniel Wang |
| Correspondent | Dennis Francoeur Iterative Scopes Inc. 14 Arrow St, 3rd Floor Cambridge, MA 02138 |
| Product Code | QNP |
| CFR Regulation Number | 876.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-08-12 |