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X-MIND optima XMO 2D CEPH DOUBLE SENSOR 100-240V

by De Götzen SRL

X-MIND optima XMO 2D CEPH DOUBLE SENSOR 100-240V (W1203009.DS) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K203374 on 5 Feb 2021 and listed in FDA GUDID since 30 Jul 2024 (UDI-DI D804W1203009DS0), active as of 22 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 22 Oct 2026

Documents

510(k) K203374

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD804W1203009DS0 UDI-DI Date30 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK203374 Date5 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203374 decided 5 Feb 2021 Active
  • FDA GUDID UDI-DI D804W1203009DS0 listed 30 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203374
  2. Listed FDA GUDID D804W1203009DS0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-MIND optima
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
XMO 2D CEPH DOUBLE SENSOR 100-240V, W1203009.DS
Primary DI / UDI-DI
D804W1203009DS0
510(k) Number
FDA product code
MUH
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary panoramic/tomographic dental x-ray system, digital

Cleared under the same submission (K203374)

and 5 more cleared under K203374

Similar devices in this category

Other devices filed under Stationary panoramic/tomographic dental x-ray system, digital.

Other devices from De Götzen SRL

See all devices from De Götzen SRL →

Properties

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