FDA.reportPublic FDA data

X-MIND optima 3D

Primary DI
D804W12030150
Brand
X-MIND optima 3D
Company
DE GÖTZEN SRL
Model
XMO 3D WALL 100-240V NO WS NO MONITOR
Catalog number
W1203015
Device description
X-MIND optima 3D, PAN/CBCT configuration, wall mounted version, without workstation and monitor
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem,X-Ray,Extraoral Source,Digital
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201382000X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.2020-11-18OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D804W12030150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure63 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01