Second Opinion
FDA 510(k) K210365 · Pearl, Inc.
510(k) numberK210365
Submission
- Device name
- Second Opinion
- Applicant
- Pearl, Inc.
Beverly Hills, CA, US - Received
- February 8, 2021
- Decision date
- March 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYN – Analyzer, Medical Image
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2070
- Specialty
- Radiology
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
Other 510(k)s with product code MYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252486 | ChestView US (1.1)MYN · Traditional | Gleamer | 09/09/2026SE |
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | Overjet, Inc. | 08/06/2026SE |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 07/15/2026SE |
| K252953 | Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional | Velmeni, Inc. | 05/11/2026SE |
| K251934 | qXR-DetectMYN · Traditional | Qure.Ai Technologies | 01/16/2026SE |
| K252934 | DiagnocatMYN · Traditional | Dgnct, LLC | 01/15/2026SE |
| K253009 | DS Core DetectMYN · Traditional | Dentsply Sirona, Inc. | 01/07/2026SE |
| K252086 | DTX Studio AssistMYN · Traditional | Nobel Biocare C/O Medicim NV | 11/17/2025SE |
| K250525 | Second Opinion® PanoramicMYN · Traditional | Pearl, Inc. | 11/14/2025SE |
| K250264 | SugarBug (1.x)MYN · Traditional | Bench7, Inc. | 11/07/2025SE |
More from Bench7, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250525 | Second Opinion® PanoramicMYN · Traditional | 11/14/2025SE |
| K243234 | Second Opinion® CSMYN · Traditional | 06/12/2025SE |
| K243989 | Second Opinion® 3DQIH · Traditional | 05/23/2025SE |
| K243230 | Second Opinion® BLEQIH · Traditional | 05/09/2025SE |
| K243893 | Second Opinion® PediatricMYN · Traditional | 05/05/2025SE |
| K242600 | Second Opinion Periapical Radiolucency ContoursMYN · Traditional | 04/11/2025SE |
| K242522 | Second Opinion CCMYN · Traditional | 01/16/2025SE |
Questions and answers
When was Second Opinion cleared by the FDA?
Second Opinion (K210365) received a 510(k) decision of Substantially Equivalent on March 4, 2022, 389 days after the submission was received.
What is the product code of K210365?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.