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X-MIND optima 3D

by De Götzen SRL 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD804W1203005FLDRT0 UDI-DI Date23 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
XMO 3D FLOOR 100-240V 1210 + WS + MONITOR, W1203005.FLDRT
Primary DI / UDI-DI
D804W1203005FLDRT0
510(k) Number
FDA Product Code
MUH, OAS
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital
Device Class
Class II
Regulation Number
872.1800, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201382)

Show all (12)

Other devices from De Götzen SRL

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No