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AutoDensity

by EOS imaging

Ref AutoDensity

AutoDensity is a Class IIa device made by Eos Imaging, cleared under FDA 510(k) K251078 on 14 Nov 2025 and registered in EUDAMED on 27 Aug 2025 (Basic UDI-DI 3663999BMD01XZ), active as of 25 Oct 2026.

Active European Union and United States

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251078↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK251078 Date14 Nov 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number3663999BMD01XZ Basic UDI-DI 03663999000344UDI-DIDate27 Aug 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251078 decided 14 Nov 2025 Active
  • EUDAMED Basic UDI-DI 3663999BMD01XZ registered 27 Aug 2025 Active

Timeline

2 dated events

  1. Registered EUDAMED 3663999BMD01XZ
  2. Cleared FDA 510(k) K251078

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  • Withdrawn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)

Model / reference
AutoDensity
Primary DI / UDI-DI
03663999000344
Basic UDI-DI
3663999BMD01XZ
Direct marketing DI
03663999000344
EMDN code
Z11900192 Bone densitometry systems - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000502

Similar devices in this category

Other devices filed under BONE DENSITOMETRY SYSTEMS.

Other devices from Eos Imaging

  • spineEOS 6.x

    Class II

  • AutoDensity 1.3

    Class II

  • VEA Align 4.x

    Class II

  • EOS System

    Class II

See all devices from Eos Imaging →

Properties

  • Measuring function
Other properties (13, all answered No)