FDA-cleared K210365
Second Opinion
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-03-04
Vendor
Pearl Inc.
8 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K242522
Second Opinion CC
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-16
FDA-cleared K242600
Second Opinion Periapical Radiolucency Contours
Pearl Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-11
FDA-cleared K243893
Second Opinion® Pediatric
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-05
FDA-cleared K243230
Second Opinion® BLE
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-09
FDA-cleared K243989
Second Opinion® 3D
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-23
FDA-cleared K243234
Second Opinion® CS
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-12
FDA-cleared K250525
Second Opinion® Panoramic
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-11-14