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Owandy-RX DC DC OWANDY 115V, SHORT CONE, MOBILE

by Owandy Radiology

Owandy-RX DC DC OWANDY 115V, SHORT CONE, MOBILE (5.92.15604) is a Class II device made by Owandy Radiology, cleared under FDA 510(k) K231055 on 28 Dec 2023 and listed in FDA GUDID since 5 Sep 2025 (UDI-DI 03760262653020), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K231055

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760262653020 UDI-DI Date5 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK231055 Date28 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231055 decided 28 Dec 2023 Active
  • FDA GUDID UDI-DI 03760262653020 listed 5 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231055
  2. Listed FDA GUDID 03760262653020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Owandy-RX DC
Generic name
Mobile intraoral dental x-ray system, digital
Model / Ref / Catalog
DC OWANDY 115V, SHORT CONE, MOBILE, 5.92.15604
Primary DI / UDI-DI
03760262653020
510(k) Number
FDA product code
EHD
GMDN term
Mobile intraoral dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mobile intraoral dental x-ray system, digital

Cleared under the same submission (K231055)

and 8 more cleared under K231055

Similar devices

Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).

Other devices from Owandy Radiology

See all devices from Owandy Radiology →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)