FDA.reportPublic FDA data

Villa Sistemi Medicali

Primary DI
08057737120312
Brand
Villa Sistemi Medicali
Company
VILLA SISTEMI MEDICALI SPA
Model
Apollo EZ DRF
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXLDevice, Spot-Film
KPWDevice, Beam Limiting, X-Ray, Diagnostic
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXLDevice, Spot-FilmRadiology2
KPWDevice, Beam Limiting, X-Ray, DiagnosticRadiology2
KXJTable, RadiologicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050190000APOLLOVilla Sistemi Medicali S.P.A.2005-03-25KXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057737120312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057737120312080577371203128057737120312

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

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
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
08057737127519Polaroid - Miri Trading LLCKeren9458A001002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00887761943209PadsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGKXJ2025-01-17
00857534006691ORT400 TableIMRIS Imaging, Inc.KXJ2024-10-04
00857534006738ORT200IMRIS Imaging, Inc.KXJ2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
00887761968424TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967632X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967649X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967656X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967724Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967786Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967885PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967915PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967939PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967519TS 7000Baxter Medical Systems GmbH + Co. KGKXJ2022-12-27