510(k) K243893
K243893 is an FDA 510(k) premarket notification submitted by Pearl, Inc. for the device "Second Opinion® Pediatric". The FDA issued a decision of Substantially Equivalent on May 5, 2025. The device falls under product code MYN (Analyzer, Medical Image), a Class II device regulated under 21 CFR 892.2070. Pearl, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2025
- Date Received
- December 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Medical Image
- Device Class
- Class II
- Regulation Number
- 892.2070
- Review Panel
- RA
- Submission Type
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