FDA.reportPublic FDA data

PantOs DG xp

Primary DI
E31584682003000
Brand
PantOs DG xp
Company
BLUO ELECTRONICS SRL
Model
8468200300
Device description
Digital Panoramic X-Ray Unit, including patient positioning items
Published
2016-09-10
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
EHDUnit, X-Ray, Extraoral With Timer
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031801000PANTOS, MODELS: PANTOS 16, AND PANTOS DGBlue X Imaging Srl2003-09-11MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E31584682003000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic 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 to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390245712171info@fonadental.it

Regulatory Flags#

DUNS number
514320345
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E3158468260320FONA ART Plus846826032097682610202023-06-12
E3158468463121FONA ART Plus C846846312197682631212023-06-12
E3158468463221FONA ART Plus C846846322197682632212023-06-12
E3159319001700FONA XDC93190017002022-09-06
E3158468600000Stellaris 3D84686000002022-04-29
E3158468600002Stellaris 3D Ceph84686000022022-04-29
E3158468600007Stellaris 2D84686000072022-04-29
E3158468600008Stellaris 2D Ceph84686000082022-04-29
E31593800001000StarX-193800001002021-09-02
E31593800002000StarX-293800002002021-09-02
E31593800011000StarX PRO-193800011002021-09-02
E31593800012000StarX PRO-293800012002021-09-02
E31562802700Vario DG62802702016-09-10
E31584682001000PantOs 16 xp84682001002016-09-10
E31584682005000PantOs 16 xp Ceph84682005002016-09-10
E31584682012000PantOs 16 xp84682012002016-09-10
E31593202013000IntraOs 7093202013002016-09-10
E31593250013000IntraOs DG93250013002016-09-10

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
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
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
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
08800003027019RAYSCANRay Co., LtdMUH2025-08-25
08800003027033RAYSCANRay Co., LtdMUH2025-08-25
08800003027040RAYSCANRay Co., LtdMUH2025-08-25
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
088000186021950909FCCRayence Co., Ltd.MQB2024-03-21
088000186022010909FCC-HSRayence Co., Ltd.MQB2024-03-21
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18