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sterEOS

by EOS imaging

Ref sterEOS

sterEOS is a device classified as Class IIa in the EU and Class II in the US made by Eos Imaging, registered in EUDAMED on 12 Jun 2023 (Basic UDI-DI 3663999RWS01A5), cleared under FDA 510(k) K172346 on 19 Jun 2018 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 03663999000047), active as of 22 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172346

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 Number3663999RWS01A5 Basic UDI-DI Date12 Jun 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172346 Date19 Jun 2018DecidedStatusActive
United StatesGUDID listing GUDID Number03663999000047 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3663999RWS01A5 registered 12 Jun 2023 Active
  • FDA 510(k) K172346 decided 19 Jun 2018 Active
  • FDA GUDID UDI-DI 03663999000047 listed 21 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-3188-2018 FDA Class II initiated 1 Aug 2018

    3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

Timeline

4 dated events

  1. Listed FDA GUDID 03663999000047
  2. Cleared FDA 510(k) K172346
  3. Recall initiated FDA recalls Z-3188-2018
  4. Registered EUDAMED 3663999RWS01A5

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

Generic name
Basic x-ray clinical assessment support software
Model / reference
sterEOS EUDAMED
Workstation 1.8 GUDID
1.10 GUDID
Software 1.8 GUDID
Primary DI / UDI-DI
03663999000047, 03663999000153, 03663999000054
Basic UDI-DI
3663999RWS01A5
Direct marketing DI
03663999000047
03663999000153
03663999000054
510(k) Number
FDA product code
LLZ
EMDN code
Z11069005, Z11030592
GMDN term
Basic x-ray clinical assessment support 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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
sterEOS
GUDID
Workstation 1.8
1.10
Software 1.8
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
FR-MF-000000502

Related devices

Category: Tissue specimen x-ray system IVD

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Eos Imaging

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  • EOS System

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See all devices from Eos Imaging →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number YesGUDIDNoGUDID
  • Manufacturing date YesGUDIDNoGUDID
Other properties (20, all answered No)