x-mind dc
x-mind dc (5.92.15109) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K231055 on 28 Dec 2023 and listed in FDA GUDID since 4 Sep 2025 (UDI-DI D804592151090), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD804592151090 | Date4 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231055 | Date28 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K231055
Across registries
- FDA 510(k) K231055 decided 28 Dec 2023 Active
- FDA GUDID UDI-DI D804592151090 listed 4 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K231055
- Listed FDA GUDID D804592151090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / Ref / Catalog
- DC X-MIND 115V, SHORT CONE, TOP 110 (16” - 40, 64cm), 5.92.15109
- Primary DI / UDI-DI
- D804592151090
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
- CRANEX BASEX D OR CRANEX EXCEL D by Soredex Palodex Group OY
- KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 by Practiceworks, Inc.
- LASER - 1000 by Panoramic Corp.
- DIXI 2 by Planmeca Oy
- DEGOTZEN SYNCHRO by The Gotzen Group, Inc.
- VIPERSOFT by Integra Medical
- MobileX Portable X-ray System by Denterprise International, Inc.
- SENS-A-RAY by Regam Medical Systems
- Portable X-ray System by ROLENCE ENTERPRISE INC.
- EZER, Portable X-ray System by LIVERMORETECH,INC