Second Opinion Periapical Radiolucency Contours
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Pearl, Inc.
Identifiers
- 510(k) Number
- K242600 FDA 510(k)
- FDA Product Code
- MYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2070 FDA 510(k)
- Regulation Number
- 892.2070 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Second Opinion Periapical Radiolucency Contours is a medical image analyzer designed for radiology applications. It provides diagnostic support by identifying and delineating periapical radiolucencies in dental radiographs, aiding in the assessment of periapical pathology such as cysts or granulomas.
This device is supplied as a software-based tool for use in clinical radiology settings. It operates on pre-existing dental radiographs and is intended for single-use per image analysis, with no sterility requirements. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization. Compliance with regulatory standards ensures its integration into radiology workflows for secondary diagnostic review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242600 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pearl, Inc.
Sources (2)
- FDA 510(k) K242600 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026