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EOSedge™ 2.1

by Eos Imaging

EOSedge™ 2.1 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K233920 on 6 Aug 2024 (1 earlier submission) and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 03663999000108), active as of 12 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK233920 Date6 Aug 2024IssuedStatusActive
United StatesGUDID listing Number03663999000108 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233920 decided 6 Aug 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03663999000108 listed 27 Feb 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1415-2021 FDA Class II initiated 22 Dec 2020

    Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

Timeline

4 dated events

  1. Listed FDA GUDID 03663999000108
  2. Cleared FDA 510(k) K202394
  3. Recall initiated FDA recalls Z-1415-2021
  4. Cleared FDA 510(k) K233920

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EOSedge™
Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
2.1
Primary DI / UDI-DI
03663999000108
FDA product code
KPR
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary basic diagnostic x-ray system, digital

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)