FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Second Opinion
K Number: K210365
·
Decision Mar 4, 2022
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
8
Review Days
389
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Basic Information
- Device Name
- Second Opinion
- K Number
- K210365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pearl, Inc.
- Date Received
- February 8, 2021
- Decision Date
- March 4, 2022
- Product Code
- MYN
- 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 |
|---|---|---|---|
| MYN | Analyzer, Medical Image | 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 |
| K243989 | Second Opinion® 3D | May 23, 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 |