FDA.reportPublic FDA data

X-MIND trium

Primary DI
D804W09000060
Brand
X-MIND trium
Company
DE GÖTZEN SRL
Model
XMT PAN 3D R CEPH L
Catalog number
W0900006
Device description
X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the right side including one removable ceph sensor ceph arm on the left
Published
2016-12-15
Public version status
Update
Distribution status
Not 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
K160166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160166000X-MIND triumDe Gotzen S.R.L.2016-11-15OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D804W09000060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure85 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
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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