FDA.reportPublic FDA data

Villa Sistemi Medicali

Primary DI
08057737125218
Brand
Villa Sistemi Medicali
Company
VILLA SISTEMI MEDICALI SPA
Model
Rotograph EVO D
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057737125218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057737125218080577371252188057737125218

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.

Regulatory Flags#

DUNS number
439173964
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057737122217Villa Sistemi MedicaliDRF 43432023-08-29
08057737122262Villa Sistemi MedicaliDRF 4343 FL2023-08-29
08057737122361Villa Sistemi MedicaliDRF 4343-TS2023-08-29
08057737120411Philips Medical Systems DMCJuno DRF2016-09-24
08057737125010Villa Sistemi MedicaliRotograph EVO2016-09-24
08057737125416Villa Sistemi MedicaliRotograph EVO 3D2016-09-24
08057737126017Villa Sistemi MedicaliEndograph DC2016-09-24
08057737126215Villa Sistemi MedicaliEndos AC2016-09-24
08057737126413Villa Sistemi MedicaliEndos ACP2016-09-24
08057737126512Owandy RadiologyElios2016-09-24
08057737126611Villa Sistemi MedicaliExplor-X AC2016-09-24
08057737126819Villa Sistemi MedicaliExplor-X ACP2016-09-24
08057737127212Villa Sistemi MedicaliVideograph HD94580001002016-09-24
08057737127229Villa Sistemi MedicaliVideograph HD94580002002016-09-24
08057737127311Villa Sistemi MedicaliVideograph94580003002016-09-24
08057737127328Villa Sistemi MedicaliVideograph94580004002016-09-24
08057737127410Polaroid - Miri Trading LLCKeren HD9458B001002016-09-24
08057737127427Polaroid - Miri Trading LLCKeren HD9458B002002016-09-24
08057737127519Polaroid - Miri Trading LLCKeren9458A001002016-09-24
08057737127526Polaroid - Miri Trading LLCKeren9458A002002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
D678J1205E0ScanX Duo TouchAIR TECHNIQUES, INC.MUH2026-03-27