FDA.reportPublic FDA data

Cone beam computed tomography system, head/neck

Definition
A 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.
GUDID devices
134
Last updated
2026-07-30 21:32:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00854810007168CLARISIcRco, Inc.CBCT2026-07-22
04589557760026PreXion3D ExplorerPREXION CORPORATIONP01A2019-08-07
04589557760033PreXion3D Explorer EXPREXION CORPORATIONP01A-EX2020-06-10
06974566270174FUSSENFussen Technology Co., Ltd.Matrix 7800 Configuration 32025-11-21
08057737125416Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPARotograph EVO 3D2016-09-24
06974566270167FUSSENFussen Technology Co., Ltd.Matrix 7800 Configuration 22025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.Matrix 7000 Configuration 22025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.Matrix 7000 Configuration 12025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.Matrix 7800 Configuration 12025-11-24
00860008443755MiniCATIQ+XORAN TECHNOLOGIES LLC100402024-10-02
00860012510900See Factor CT3EPICA HUMAN HEALTH LLC98011010002024-09-09
04589557760071PreXion3D ExpeditionPREXION CORPORATIONP04B2024-05-20
07899581340642Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202024-02-23
07899581340659Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202024-02-23
07899581340734SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581340741SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR120 B2024-02-23
07899581340758SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581340765SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581340772SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR120 B2024-02-23
07899581340789SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR120 B2024-02-23
07899581340796SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR120 B2024-02-23
07899581344732SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581345012SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581345029SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581345043SXR / SaevoAlliage S/A Indústrias Médico OdontológicaAXR90 B2024-02-23
07899581345128Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902024-02-23
07899581345135Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902024-02-23
00860008443731MiniCATIQXORAN TECHNOLOGIES LLC100152024-01-29
60192155944864CS 8200 3D AccessCARESTREAM DENTAL LLC59448632023-12-12
07899581344985PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR902023-12-08
07899581344992PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR902023-12-08
07899581345005PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR902023-12-08
07899581345067PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR902023-12-08
07899581345081PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR1202023-12-08
07899581345098PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR1202023-12-08
07899581345104PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR1202023-12-08
07899581345111PREXION EVOLVEAlliage S/A Indústrias Médico OdontológicaAXR1202023-12-08
07899581335525Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581335532Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581335549Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581335556Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202023-10-18
07899581335563Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202023-10-18
07899581335570Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202023-10-18
07899581335587Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR1202023-10-18
07899581339196Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581339615Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581339622Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
07899581339639Dental CT Scanner AXRAlliage S/A Indústrias Médico OdontológicaAXR902023-10-18
08033837931348NewTomCEFLA SOCIETA' COOPERATIVANewTom VGi evo2016-10-03
03760262650210Owandy RadiologyOWANDY RADIOLOGYI-Max Touch 3D2016-09-24
04589557760057PreXion3D ExpeditionPREXION CORPORATIONP04A2023-02-28
04589557760040PreXion3D Explorer PROPREXION CORPORATIONP03A2022-06-28
D090083060000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.60002022-03-04
D090083063000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.63002022-03-04
D090083065000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.65002022-03-04
D090083081000OP 3D VisionDental Imaging Technologies Corporation0.830.81002022-03-04
D090083082000OP 3D VisionDental Imaging Technologies Corporation0.830.82002022-03-04
D090083083000OP 3D VisionDental Imaging Technologies Corporation0.830.83002022-03-04
E247A78610ProVecta 3D Prime CephDÜRR DENTAL SEA78612022-03-04
EKAV083081000KaVo OP 3D VisionDental Imaging Technologies Corporation0.830.81002022-01-21
EKAV083082000KaVo OP 3D VisionDental Imaging Technologies Corporation0.830.82002022-01-21
EKAV083083000KaVo OP 3D VisionDental Imaging Technologies Corporation0.830.83002022-01-21
04548213053261Veraview FX800J.MORITA MFG.CORP.X800N2021-07-15
00860005941605SeeFactorCT3Epica Medical Innovations LLCSeeFactorCT32021-06-30
86000594161101SeeFactor CT3Epica Medical Innovations LLC98011010002021-03-22
E247A77500ProVecta 3D PrimeDÜRR DENTAL SEA77502021-02-02
E247A77610ProVecta 3D PrimeDÜRR DENTAL SEA77612021-02-02
E247A78500ProVecta 3D Prime CephDÜRR DENTAL SEA78502021-02-02
D804W12000100X-MIND prime 3DDE GÖTZEN SRLXMP 3D CEPH 110-240V + WS + MONITOR2020-11-30
60192155943218CS 8200 3DCARESTREAM DENTAL LLC59432122020-06-22
60192155943232SCAN CEPHCARESTREAM DENTAL LLC59432382020-06-22
EKAV083000000Kavo 3D eXam™ imaging systemDental Imaging Technologies Corporation0.830.00002016-09-24
EKAV083010000Kavo 3D eXam i™ imaging systemDental Imaging Technologies Corporation0.830.10002016-09-24
EKAV083020000Gendex CB-500™ imaging systemDental Imaging Technologies Corporation0.830.20002016-09-24
EKAV083030000Gendex CB-500™ HD imaging systemDental Imaging Technologies Corporation0.830.30002016-09-24
EKAV083040000i-CAT 17-19™ imaging systemDental Imaging Technologies Corporation0.830.40002016-09-24
EKAV083050000i-CAT Precise™ imaging systemDental Imaging Technologies Corporation0.830.50002016-09-24
EKAV083060000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.60002016-09-24
EKAV083063000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.63002016-10-17
EKAV083065000i-CAT FLX™ imaging systemDental Imaging Technologies Corporation0.830.65002016-10-17