FDA.reportPublic FDA data

Villa Sistemi Medicali

Primary DI
08057737122361
Brand
Villa Sistemi Medicali
Company
VILLA SISTEMI MEDICALI SPA
Model
DRF 4343-TS
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080859000DRF 4343Villa Sistemi Medicali S.P.A.2008-06-04JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057737122361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057737122361080577371223618057737122361

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
439173964
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057737122040Villa Sistemi MedicaliDRF 4343-LT System DT87840000032026-06-04
08057737122057Villa Sistemi MedicaliDRF 4343-LT System DT87930000012026-06-04
08057737122217Villa Sistemi MedicaliDRF 43432023-08-29
08057737122262Villa Sistemi MedicaliDRF 4343 FL2023-08-29
08057737120411Philips Medical Systems DMCJuno DRF2016-09-24
08057737125010Villa Sistemi MedicaliRotograph EVO2016-09-24
08057737125218Villa Sistemi MedicaliRotograph EVO D2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00810035220546Radmedix AcuityDRe 1717tRADMEDIX, LLCMQB2025-10-28
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
D0031000082900SchickDentsply International Inc.MQB2024-11-06
D0031000085860SchickDentsply International Inc.MQB2024-11-06
D0031000085870SchickDentsply International Inc.MQB2024-11-06
D0031000085880SchickDentsply International Inc.MQB2024-11-06
D0031000086260SchickDentsply International Inc.MQB2024-11-06
D0031000086300SchickDentsply International Inc.MQB2024-11-06
D0031000086350SchickDentsply International Inc.MQB2024-11-06
D0031000086360SchickDentsply International Inc.MQB2024-11-06
D0031000086380SchickDentsply International Inc.MQB2024-11-06
D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06