Class Class II
Second Opinion® Pediatric (K243893)
Description
Second Opinion® Pediatric by Pearl, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243893
Clearance Date2025-05-05
Clearance TypeTraditional
Product CodeMYN
Regulation Number892.2070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243893
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Second Opinion® Pediatric (K243893) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210365 | Second Opinion | Pearl, Inc. | 2022 |
Trace the full predicate network for K243893
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.