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Deep Learning Image Reconstruction

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 5869275510(k) K230807Ref 5928863Model ver 1.1, ver 1.2

by GE Healthcare Japan Corporation

Identity

Trade Name
Deep Learning Image Reconstruction EUDAMED
DLIR FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
Deep Learning Image Reconstruction EUDAMED
DLIR Application Container for Smart Subscription FDA UDI
SWMD DLIR Application for Smart Subscription FDA UDI
Model / Reference
5869275 EUDAMED
5928863 EUDAMED
ver 1.1, ver 1.2 EUDAMED
1.1 FDA UDI
1.2 FDA UDI
Description
DLIR Application Container for Smart Subscription FDA UDI
SWMD DLIR Application for Smart Subscription FDA UDI

Identifiers

Catalog Number
5928863 FDA UDI
Primary DI / UDI-DI
00195278303202 EUDAMEDFDA UDI
00195278620453 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00032GR EUDAMED
510(k) Number
K193170 FDA UDI
K212067 FDA UDI
K220961 FDA UDI
K230807 FDA UDI
FDA Product Code
JAK FDA UDI
EMDN Code
Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The Deep Learning Image Reconstruction is a radiological image processing system (Nomenclature Code: Z11030692) designed to enhance computed tomography (CT) and CT angiography (CTA) image quality through deep learning algorithms. It processes raw scan data to generate sharper, clearer images with reduced noise while preserving anatomical details, improving diagnostic confidence and workflow efficiency.

This software-based solution is non-sterile, non-reusable, and non-implantable, intended for use with compatible CT systems. Supplied as a digital application, it requires no reprocessing or sterilization and is classified as Class IIa under FDA 510(k) clearance (Reference: 5869275, K230807). Compliance with MDR regulations is also noted. The device operates in radiology settings and is assigned a Basic UDI: 8406821BUG00032GR for traceability.

Frequently asked questions

What types of imaging studies is the Deep Learning Image Reconstruction designed to enhance, and how does it improve diagnostic outcomes?

The Deep Learning Image Reconstruction is specifically designed to enhance computed tomography (CT) and CT angiography (CTA) images. It uses deep learning algorithms to process raw scan data, producing sharper, clearer images with reduced noise while maintaining anatomical details. This improvement in image quality boosts diagnostic confidence and streamlines workflow efficiency for radiologists.

How is the Deep Learning Image Reconstruction supplied, and does it require any special handling or reprocessing?

The Deep Learning Image Reconstruction is supplied as a digital application, meaning it is not a physical device but rather software integrated with compatible CT systems. Since it is non-sterile and non-reusable, no sterilization or reprocessing is required. It is intended for single-use in a radiology setting, eliminating the need for maintenance or cleaning.

Is the Deep Learning Image Reconstruction compatible with all CT systems, or are there specific models or requirements for integration?

The Deep Learning Image Reconstruction is designed for use with *compatible* CT systems, though the exact models or integration requirements are not specified in the provided data. Buyers should confirm compatibility with their existing equipment before implementation, as this software-based solution relies on seamless integration with the host CT system.

How is the regulatory status of this device classified, and what does that mean for healthcare providers?

The Deep Learning Image Reconstruction is classified as Class IIa under FDA 510(k) clearance (K230807) and complies with the Medical Device Regulation (MDR). This classification indicates a moderate risk level, meaning it has undergone regulatory review to ensure safety and performance. For healthcare providers, this means the device has met established standards for quality and effectiveness, though they should always refer to the latest regulatory documentation for specific usage guidelines.

What should be considered when storing or maintaining the Deep Learning Image Reconstruction software?

Since the Deep Learning Image Reconstruction is a digital application, storage primarily involves ensuring the host CT system’s software environment remains updated and compatible. No physical storage requirements (like shelf life or temperature controls) apply, as the device is non-sterile and non-reusable. However, healthcare facilities should follow the manufacturer’s guidelines for software updates, backups, and system maintenance to ensure continued functionality and compliance.

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: GE Healthcare Japan - Physician AI Tools, Deep Learning Image Reconstruction | GE Healthcare Japan Corporation ..., Deep-learning imaging reconstruction: Improving IQ and patient outcomes ..., Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation ..., General Electric Healthcare Japan | Radiology AI Companies

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
GE Healthcare Japan Corporation
EUDAMED SRN
JP-MF-000009291
Authorised Representative
GE Medical Systems SCS FR-AR-000000344

Sources (7)

  • EUDAMED 38d0570c-aea8-4fd6-8515-e4814acb80a0 85 fields · synced Sep 18, 2026
  • EUDAMED f909b8b4-1eff-4397-acea-d4be53e7f856 61 fields · synced May 19, 2026
  • FDA UDI 7af0fad3-aba9-4274-a0e8-99254037dbb7 34 fields · synced May 29, 2026
  • FDA UDI 24f27b81-dc16-445a-92c3-e395735414d4 35 fields · synced May 30, 2026
  • EUDAMED b3e3fbd1-a34b-446f-80f7-b29c1b2ea3d7 61 fields · synced Jul 9, 2026
  • EUDAMED ef5a9213-cd14-483e-80c4-87aaff398fe6 61 fields · synced Jul 22, 2026
  • FDA 510(k) K193170 1 fields · synced May 18, 2026