# Deep Learning Image Reconstruction

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/deep-learning-image-reconstruction-5869275>
- Manufacturer: [GE Healthcare Japan Corporation](https://devicerts.com/manufacturers/fda-fei-3002808529) (Japan)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: JAK
- EMDN: Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
- EMDN: Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
- GMDN: CT system application software (40867)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8406821BUG00032GR · registered 2023-10-28 · status: Active
- **510(k)** · FDA 510(k) · United States · K230807 · issued 2023-04-20 · status: Active
- **510(k)** · FDA 510(k) · United States · K220961 · issued 2022-07-29 · status: Active
- **510(k)** · FDA 510(k) · United States · K212067 · issued 2021-09-17 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00195278303202 · listed 2021-08-25 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K193170 · issued 2019-12-13 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: Deep Learning Image Reconstruction [EUDAMED]; DLIR [FDA GUDID (AccessGUDID)]
- Generic name: CT system application software [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: ver 1.1 [EUDAMED]; ver 1.2 [EUDAMED]; 5869275 [EUDAMED, FDA GUDID (AccessGUDID)]; 5928863 [EUDAMED, FDA GUDID (AccessGUDID)]; 1.1 [FDA GUDID (AccessGUDID)]; 1.2 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00195278303202 [EUDAMED, FDA GUDID (AccessGUDID)]; 00195278620453 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8406821BUG00032GR [EUDAMED]
- 510(k) Number: K193170 [FDA GUDID (AccessGUDID)]; K212067 [FDA GUDID (AccessGUDID)]; K220961 [FDA GUDID (AccessGUDID)]; K230807 [FDA GUDID (AccessGUDID)]
- FDA product code: JAK [FDA GUDID (AccessGUDID)]
- EMDN code: Z11030692 [EUDAMED]; Z11030682 [EUDAMED]
- GMDN term: CT system application software (40867) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1750 [FDA GUDID (AccessGUDID)]
- Special device type: Software [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Deep Learning Image Reconstruction, GE Healthcare Japan Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/deep-learning-image-reconstruction-5869275 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/deep-learning-image-reconstruction-5869275.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/deep-learning-image-reconstruction-5869275
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.