FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Second Opinion® 3D
K Number: K243989
·
Decision May 23, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
8
Review Days
148
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Basic Information
- Device Name
- Second Opinion® 3D
- K Number
- K243989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pearl, Inc.
- Date Received
- December 26, 2024
- Decision Date
- May 23, 2025
- 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 Pearl, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250525 | Second Opinion® Panoramic | Nov 14, 2025 | Substantially Equivalent |
| K243234 | Second Opinion® CS | Jun 12, 2025 | Substantially Equivalent |
| K243230 | Second Opinion® BLE | May 9, 2025 | Substantially Equivalent |
| K243893 | Second Opinion® Pediatric | May 5, 2025 | Substantially Equivalent |
| K242600 | Second Opinion Periapical Radiolucency Contours | Apr 11, 2025 | Substantially Equivalent |
| K242522 | Second Opinion CC | Jan 16, 2025 | Substantially Equivalent |
| K210365 | Second Opinion | Mar 4, 2022 | Substantially Equivalent |