Deep Learning Image Reconstruction
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183202 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Deep Learning Image Reconstruction is a software-based technology designed to process and enhance medical imaging data. It utilizes deep learning algorithms to reconstruct images, aiming to improve diagnostic clarity and image quality.
This device is regulated under FDA 510K clearance. It is intended for use within radiology clinical workflows to support diagnostic imaging procedures.
Frequently asked questions
What is the primary purpose of Deep Learning Image Reconstruction?
This software-based technology is designed to process and enhance medical imaging data. By utilizing deep learning algorithms to reconstruct images, it aims to improve diagnostic clarity and overall image quality within radiology clinical workflows.
How is this software regulated?
Deep Learning Image Reconstruction is regulated under FDA 510K clearance, identified by the K-number K183202. It was determined to be substantially equivalent to existing devices through a traditional review process.
In what clinical environment is this device intended to be used?
The software is intended for use specifically within radiology clinical workflows. It is designed to support diagnostic imaging procedures by providing enhanced image processing capabilities.
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: Deep-learning imaging reconstruction: Improving IQ and patient outcomes ..., GE HealthCare broadens its deep learning CT portfolio with FDA ..., AIR Recon DL | GE HealthCare (United States)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183202 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K183202 24 fields · synced Sep 26, 2026