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Deep Learning Image Reconstruction

by GE Healthcare Japan Corporation

Ref 5869275, 5928863Model ver 1.1, ver 1.2

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230807↗

+3 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00032GR Basic UDI-DI Date28 Oct 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK230807 Date20 Apr 2023IssuedStatusActive
United StatesGUDID listing GUDID Number00195278303202 UDI-DI Date25 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00032GR registered 28 Oct 2023 Active
  • FDA 510(k) K230807 decided 20 Apr 2023 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00195278303202 listed 25 Aug 2021 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K193170
  2. Listed FDA GUDID 00195278303202
  3. Cleared FDA 510(k) K212067
  4. Cleared FDA 510(k) K220961
  5. Cleared FDA 510(k) K230807
  6. Registered EUDAMED 8406821BUG00032GR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
Deep Learning Image Reconstruction EUDAMED
Dlir GUDID
Generic name
CT system application software
Model / Ref / Catalog
ver 1.1, ver 1.2, 5869275, 5928863, 1.1, 1.2
Primary DI / UDI-DI
00195278303202, 00195278620453
Basic UDI-DI
8406821BUG00032GR
510(k) Number
FDA product code
JAK
EMDN code
Z11030692, Z11030682
GMDN term
CT system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1750
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ver 1.1, ver 1.2
5869275
5928863
GUDID
1.1
1.2
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
JP-MF-000009291
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)