Identifiers
- 510(k) Number
- K012563 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Deep Gray is a medical imaging system. It is designed to function as a tool for the processing and analysis of medical images.
This device is supplied by Cortechs Labs Inc and has received FDA 510k clearance. It is categorized under the radiology advisory committee.
Frequently asked questions
What is the primary function of the Deep Gray system?
Deep Gray is a medical imaging system developed by Cortechs Labs Inc. It is specifically designed to serve as a tool for the processing and analysis of medical images.
What is the regulatory status of the Deep Gray system?
The Deep Gray system has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the radiology advisory committee category.
Which advisory committee oversees the Deep Gray device?
The Deep Gray system is categorized under the Radiology advisory committee. This classification is based on the device's function as an imaging tool used for medical image processing and analysis.
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. Sources consulted: Cortechs Labs Deep Gray - allmed.wiki, PDF CorTechs Labs, Inc. August 22, 2024, CORTECHS LABS, INC. FDA Filings - FDA.report, CorTechs Labs Company Profile | Management and Employees List - Datanyze
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012563 | Class II | Active |
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Manufacturer
- Manufacturer
- Cortechs Labs Inc
- FDA Applicant
- Cortechs Labs, Inc.
Sources (1)
- FDA 510(k) K012563 24 fields · synced Sep 27, 2026