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X-MIND optima

FDA UDI

Class II (US FDA UDI)

by De Götzen Srl

Identity

Trade Name
X-MIND optima FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
X-MIND optima, PAN/CEPH configuration, floor mounted version FDA UDI
Model / Reference
XMO 2D CEPH 100-240V FDA UDI
Description
X-MIND optima, PAN/CEPH configuration, floor mounted version FDA UDI

Identifiers

Catalog Number
W1203009 FDA UDI
Primary DI / UDI-DI
D804W12030090 FDA UDI
510(k) Number
K203374 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

X-MIND optima by De Götzen Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary panoramic/tomographic dental x-ray system, digital.

Cleared under the same submission

K203374 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
De Götzen Srl

Sources (1)

  • FDA UDI b0f550a4-c58a-40ab-9ea0-15ac67a34f34 37 fields · synced May 30, 2026