FDA.reportPublic FDA data

STEPHANIX

Primary DI
03664049000031
Brand
STEPHANIX
Company
STEPHANIX
Model
D2RS_B1_N
Device description
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
Published
2023-06-05
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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213479000D²RS and D²RS 9090Stephanix2021-12-23OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664049000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664049000031036640490000313664049000031

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure760 millibar1050 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1050 millibar
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381826536
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664049000017STEPHANIXD2RS2016-10-22
03664049000024STEPHANIXD2RS_AT2016-10-22
03664049902366STEPHANIXMOVIX DReamy_10202023-08-01
03664049902472STEPHANIXMOVIX DReamy_10322023-08-01
03664049902489STEPHANIXMOVIX DReamy_10402023-08-01
03664049902496STEPHANIXMOVIX DReamy_10502023-08-01
03664049000048STEPHANIXD2RS_AT_PA2023-06-05
03664049000055STEPHANIXD2RS_B1_NV22023-06-05
03664049000062STEPHANIXD2RS_AT_PA_NV22023-06-05
03664049001038STEPHANIXD2RS_9090_B1_N2023-06-05
03664049001045STEPHANIXD2RS_9090_AT_PA2023-06-05
03664049001052STEPHANIXD2RS_9090_B1_NV22023-06-05
03664049001069STEPHANIXD2RS_9090_AT_PA_NV22023-06-05

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Primary DI, Brand, Company table
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08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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