Second Opinion® CS
FDA 510(k) clearance K243234 · decided 2025-06-12
Clearance details
- K-number
- K243234
- Device name
- Second Opinion® CS
- Applicant
- Pearl, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-10
- Decision date
- 2025-06-12
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- MYN
- Device class
- 2
- Regulation number
- 892.2070
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Beverly Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Overjet Multi-Image Caries and Charting Assist (K261059) | Overjet, Inc. | 2026-08-06 |
| Better Diagnostics Dental Assist (BDDA) Version 1.0 (K260851) | Better Diagnostics AI Corp. | 2026-07-15 |
| Velmeni for Dentists (V4D) Endo-Perio (K252953) | Velmeni, Inc. | 2026-05-11 |
| qXR-Detect (K251934) | Qure.Ai Technologies | 2026-01-16 |
| Diagnocat (K252934) | DGNCT, LLC | 2026-01-15 |
| DS Core Detect (K253009) | Dentsply Sirona, Inc. | 2026-01-07 |
| DTX Studio Assist (K252086) | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| Second Opinion® Panoramic (K250525) | Pearl, Inc. | 2025-11-14 |
| SugarBug (1.x) (K250264) | Bench7, Inc. | 2025-11-07 |
| Videa Dental AI (K251002) | Videahealth, Inc. | 2025-09-19 |
| VELMENI for DENTISTS (V4D) (K250753) | Velmeni, Inc. | 2025-09-02 |
| Smile Dx® (K242437) | Cube Click, Inc. | 2025-05-14 |
Recalls involving this device
No recalls on record reference this clearance.