FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Overjet Iris Intelligent Imaging System
K Number: K253930
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
11
Review Days
122
Basic Information
- Device Name
- Overjet Iris Intelligent Imaging System
- K Number
- K253930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Overjet, Inc.
- Date Received
- December 9, 2025
- Decision Date
- April 10, 2026
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Overjet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251514 | Overjet CBCT Assist | Dec 5, 2025 | Substantially Equivalent |
| K241681 | Overjet Image Enhancement Assist | Sep 9, 2024 | Substantially Equivalent |
| K241684 | Overjet Charting Assist | Aug 27, 2024 | Substantially Equivalent |
| K233738 | Overjet Caries Assist-Pediatric | Mar 4, 2024 | Substantially Equivalent |
| K233590 | Overjet Charting Assist | Feb 23, 2024 | Substantially Equivalent |
| K231678 | Overjet Periapical Radiolucency Assist | Sep 21, 2023 | Substantially Equivalent |
| K222746 | Overjet Caries Assist | Mar 27, 2023 | Substantially Equivalent |
| K220928 | Overjet Calculus Assist | Dec 16, 2022 | Substantially Equivalent |
| K212519 | Overjet Caries Assist | May 10, 2022 | Substantially Equivalent |
| K210187 | Overjet Dental Assist | May 19, 2021 | Substantially Equivalent |