FDA 510(k) K233590, Overjet Charting Assist, by Overjet, Inc.
FDA 510(k) K233590, Overjet Charting Assist, by Overjet, Inc.
| 510(k) Number | K233590 |
| Device Classification Name | Automated Radiological Image Processing Software |
| Device Name | Overjet Charting Assist |
| Applicant | Overjet, Inc. 50 Milk St. 16th Floor Boston, MA 02109 |
| Regulation Number | 892.205 |
| Classification Product Code | QIH |
| Date Received | 11/08/2023 |
| Decision Date | 02/23/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1343 |
| Redacted Pages | 655 |
| Unredacted Pages | 688 |
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