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Deep Recon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193073

by Shanghai United Imaging Healthcare Co., Ltd.

Identifiers

510(k) Number
K193073 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 Recon is a deep-learning-based CT reconstruction method designed for axial, helical, and cardiac imaging acquisitions. It leverages artificial intelligence to enhance image quality and diagnostic accuracy in computed tomography scans, falling under the category of System, X-ray, Tomography, Computed (product code JAK).

This device is supplied as part of a CT scanner system and is intended for use in radiology settings. It is cleared under FDA 510(k) with K-number K193073, classified as substantially equivalent to a predicate device. No explicit mention of sterility, single-use, or MRI safety is provided in the available data.

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: United Imaging Healthcare Deep Recon - allmed.wiki, Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. radiology AI ..., Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | Aletia Index, K193073 - Deep Recon - Radiology

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.

Sources (1)

  • FDA 510(k) K193073 24 fields · synced Oct 6, 2026