Skip to content

EDDA TECHNOLOGY IQQA-BodyImaging

by EDDA Technology, Inc.

Ref IQQA-BodyImaging

EDDA TECHNOLOGY IQQA-BodyImaging is a device classified as Class IIa in the EU and Class II in the US made by EDDA Technology, Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 08684660002BI01RA), cleared under FDA 510(k) K141745 on 31 Oct 2014 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00868466000220), active as of 22 Oct 2026.

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141745

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08684660002BI01RA Basic UDI-DI 00868466000220UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00868466000220 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141745 Date31 Oct 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08684660002BI01RA registered 19 May 2026 Active
  • FDA 510(k) K141745 decided 31 Oct 2014 Active
  • FDA GUDID UDI-DI 00868466000220 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141745
  2. Listed FDA GUDID 00868466000220
  3. Registered EUDAMED 08684660002BI01RA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
IQQA®-BodyImaging, IQQA-BodyImaging EUDAMED
Edda Technology GUDID
Generic name
Radiology DICOM image processing application software
Model / reference
IQQA-BodyImaging
Primary DI / UDI-DI
00868466000220
Basic UDI-DI
08684660002BI01RA
510(k) Number
FDA product code
LLZ
EMDN code
Z11030592 Radiology instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from EDDA Technology, Inc.

See all devices from EDDA Technology, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)