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X-MIND trium XMT PAN 3D R CEPH L

by De Götzen SRL

X-MIND trium XMT PAN 3D R CEPH L (W0900006) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K160166 on 15 Nov 2016 and listed in FDA GUDID since 15 Dec 2016 (UDI-DI D804W09000060), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K160166

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 NumberD804W09000060 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK160166 Date15 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160166 decided 15 Nov 2016 Active
  • FDA GUDID UDI-DI D804W09000060 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160166
  2. Listed FDA GUDID D804W09000060

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  • Withdrawn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 trium
Generic name
Cone beam computed tomography system, head/neck
Model / Ref / Catalog
XMT PAN 3D R CEPH L, W0900006
Primary DI / UDI-DI
D804W09000060
510(k) Number
FDA product code
MUH, OAS
GMDN term
Cone beam computed tomography system, head/neck
Device class
Class II
Regulation number
872.1800, 892.1750
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MUH (System,X-Ray,Extraoral Source,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)