FDA.reportPublic FDA data

Discovery RF180

Primary DI
08054890480123
Brand
Discovery RF180
Company
GENERAL MEDICAL MERATE SPA
Model
OPERA D4000RF
Device description
It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.
Published
2018-07-11
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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173395000
K213081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173395000MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A2018-05-21JAA
K213081000CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A2021-10-26IZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054890480123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054890480123080548904801238054890480123

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428658934
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054890480048OPERA SWINGOPERA D4000RF2016-09-22
08054890480055CLISIS SYSTEMSCLISIS SYSTEMS2018-07-11
08054890480079CLISIS SYSTEMSOPERA D4000RF2018-07-11
08054890480109Discovery RF180Discovery RF1802018-07-11
08054890480161Discovery RF180WST-SX2019-04-12
08054890480178Discovery RF180WS-DX2019-04-12
08054890480185Discovery RF180WS-SX2019-04-12
08054890480024Discovery RF180KALOS2018-07-11
08054890480062CLISIS SYSTEMSCLISIS EXEL DRF2018-07-11
08054890480086CLISIS SYSTEMSWS2018-07-11
08054890480093CLISIS SYSTEMSKALOS2018-07-11
08054890480116Discovery RF180CLISIS EXEL DRF2018-07-11
08054890480130Discovery RF180WST-DX2018-07-11
08054890480147THALESPixium 2430EZ2019-02-10
08054890480154THALESPixium 3543EZ2019-02-10
08054890480000OPERA SWINGX-RAY R&F REMOTE SYSTEM OPERA SWING2016-09-22
08054890480017OPERA SWINGX-RAY REMOTE TABLE OPERA SWING2016-09-22
08054890480031OPERA SWINGSTRETCHER2016-09-22

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