Second Opinion CC Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Pearl, Inc.
Identifiers
- 510(k) Number
- K242522 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 CC Analyzer is a medical imaging device classified as an Analyzer, designed for the evaluation and analysis of medical images. It falls under the category of radiology equipment, specifically intended for secondary review and diagnostic support in radiologic assessments.
This device is supplied as a reusable medical instrument, intended for use in radiology settings. It operates under FDA 510(k) clearance and EU MDR authorization, adhering to regulatory standards for Class II devices. The analyzer is not specified as MRI-safe or sterile, and its usage is governed by the regulatory framework outlined in 21 CFR 892.2070, with a product code of MYN.
Frequently asked questions
What is the primary purpose of the Second Opinion CC Analyzer in a clinical setting?
The Second Opinion CC Analyzer is designed specifically for secondary review and diagnostic support in radiologic assessments. It helps radiologists evaluate and analyze medical images to assist in making more informed diagnostic decisions, serving as a tool for double-checking initial interpretations.
Is the Second Opinion CC Analyzer intended for single-use or reusable applications?
The Second Opinion CC Analyzer is supplied as a reusable medical instrument, meaning it is designed for repeated use within radiology settings after proper cleaning and maintenance. It is not intended for single-use.
What regulatory pathways does the Second Opinion CC Analyzer follow, and where is it authorized?
The Second Opinion CC Analyzer follows the FDA 510(k) clearance pathway and is authorized under the EU Medical Device Regulation (MDR). It is classified as a Class II device in both regulatory frameworks, ensuring it meets stringent standards for safety and performance in radiologic imaging analysis.
Does the Second Opinion CC Analyzer come with any specific storage or handling requirements?
While the device is reusable, the manufacturer does not specify sterility or MRI safety in the provided data. Proper storage should follow general guidelines for reusable medical imaging equipment, including protection from physical damage, dust, and environmental contaminants. Always refer to the manufacturer’s instructions for specific cleaning, maintenance, and storage protocols.
Are there different models or sizes available for the Second Opinion CC Analyzer?
The provided data lists multiple registration numbers (e.g., 3017840913, 3024891354) under the product code MYN, which may indicate variations in software versions, firmware updates, or minor hardware configurations. However, no explicit details on distinct physical sizes or models are provided. For precise model specifications, consult the manufacturer’s documentation or contact Pearl, Inc.
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 | K242522 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pearl, Inc.
Sources (2)
- FDA 510(k) K242522 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026