FDA.reportPublic FDA data

Acteon Imaging Suite

Primary DI
D804W09000460
Brand
Acteon Imaging Suite
Company
DE GÖTZEN SRL
Model
ACTEON IMAGING SUITE
Catalog number
W0900046
Device description
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. Itcontrols exam retrieval, display, enhancement, and saving of digital images from various digital imagingsystems. It stores and communicates these images within the system or across computer systems atdistributed locations.
Published
2020-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192165000Acteon Imaging SuiteDe Gotzen S.R.L.2020-02-11LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D804W09000460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Panoramic/tomographic dental x-ray system application softwareAn application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. A basic set of applications programs and routines are included with any computer-controlled diagnostic imaging system. Some applications software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390331376760imaging.italysupport@acteongroup.com

Regulatory Flags#

DUNS number
433051802
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D804W1203005DRT0X-MIND optima 3DXMO 3D WALL 100-240V 1210 + WS + MONITORW1203005.DRT2026-03-23
D804W1203005FLDRT0X-MIND optima 3DXMO 3D FLOOR 100-240V 1210 + WS + MONITORW1203005.FLDRT2026-03-23
D804W1203010DRT0X-MIND optima 3DXMO 3D CEPH 100-240V 1210 + WS + MONITORW1203010.DRT2026-03-23
D804W1203015DRT0X-MIND optima 3DXMO 3D WALL 100-240V 1210 NO WS NO MONITORW1203015.DRT2026-03-23
D804W1203015FLDRT0X-MIND optima 3DXMO 3D FLOOR 100-240V 1210 NO WS NO MONITORW1203015.FLDRT2026-03-23
D804W1203020DRT0X-MIND optima 3DXMO 3D CEPH 100-240V 1210 NO WS NO MONITORW1203020.DRT2026-03-23
D804592151000x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 40 (16” - 40,64cm)5.92.151002025-09-04
D804592151010x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 80 (16” - 40,64cm)5.92.151012025-09-04
D804592151020x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)5.92.151022025-09-04
D804592151070x-mind dcDC X-MIND 115V,SHORT CONE,TOP 40 (16” - 40,64cm)5.92.151072025-09-04
D804592151080x-mind dcDC X-MIND 115V,SHORT CONE,TOP 80 (16” - 40,64cm)5.92.151082025-09-04
D804592151090x-mind dcDC X-MIND 115V,SHORT CONE,TOP 110 (16” - 40,64cm)5.92.151092025-09-04
D804592151100x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 40 (16” - 40,645.92.151102025-09-04
D804592151110x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 80 (16” - 40,645.92.151112025-09-04
D804592151120x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 110 (16” - 40,65.92.151122025-09-04
D804592151170x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 40 (16” - 40,64c5.92.151172025-09-04
D804592151180x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 80 (16” - 40,64c5.92.151182025-09-04
D804592151190x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 110 (16” - 40,645.92.151192025-09-04
D804W13000050U-SENSE HDU-SENSE HD SIZE 1.5W13000052025-05-15
D804W13000010U-SENSEU-SENSE SIZE 1W13000012020-02-27

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