FDA.reportPublic FDA data

X-MIND prime

Primary DI
D804W12000030
Brand
X-MIND prime
Company
DE GÖTZEN SRL
Model
XMP 2D COLUMN 110-240V
Catalog number
W1200003
Device description
X-MIND prime PAN only version coulmn version open range
Published
2019-10-16
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
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

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
D804W12000030PrimaryHIBCC0

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 Pressure70 KiloPascal106 KiloPascal
Handling Environment Atmospheric Pressure85 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure63 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
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

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
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
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
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01