← Back to catalogue

Acteon Imaging Suite

FDA UDI

Class II (US FDA UDI)

by De Götzen Srl

Identity

Trade Name
Acteon Imaging Suite FDA UDI
Generic Name
Panoramic/tomographic dental x-ray system application software FDA UDI
Device Name
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. It is distributed on DVD FDA UDI
Model / Reference
ACTEON IMAGING SUITE (DVD): FDA UDI
Description
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. It is distributed on DVD FDA UDI

Identifiers

Catalog Number
990263 FDA UDI
Primary DI / UDI-DI
D8049902630 FDA UDI
510(k) Number
K192165 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Panoramic/tomographic dental x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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: Panoramic/tomographic dental x-ray system application software

Acteon Imaging Suite by De Götzen Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Panoramic/tomographic dental x-ray system application software.

Cleared under the same submission

K192165 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
De Götzen Srl

Sources (1)

  • FDA UDI 53d6d337-2a05-4d35-a18e-ce863416dd28 36 fields · synced May 30, 2026