FDA.reportPublic FDA data

C015

Primary DI
08053470960000
Brand
C015
Company
MICRONICA SRL
Model
FP XS C015
Device description
Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
Published
2020-03-16
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
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192182000C015Micronica Srl2020-01-17OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053470960000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053470960000080534709600008053470960000

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
428699566
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053470960017C015FP XL C0152020-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
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08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00857088008684TrackXTrackX Technology, LLCOWB2026-05-11
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
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00841962120555Alpine Stirrups, Metric, RightQfixOWB2026-04-14
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00850073646120TrackXTrackX Technology, LLCOWB2026-04-08
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-03-25
00850079606050EmitterOXOS Medical, Inc.OWB2026-03-25
00850073646106TrackXTrackX Technology, LLCOWB2026-02-24
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00841962120388Lumen AirShuttleQfixOWB2025-12-02
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
00850073646045TrackXTrackX Technology, LLCOWB2025-10-24
00850073646052TrackXTrackX Technology, LLCOWB2025-10-24
00850073646069TrackXTrackX Technology, LLCOWB2025-10-24
00850073646076TrackXTrackX Technology, LLCOWB2025-10-24
00850073646083TrackXTrackX Technology, LLCOWB2025-10-24
00850073646113TrackXTrackX Technology, LLCOWB2025-10-15
00841962119467Alpine StirrupsQfixOWB2025-07-09
00841962119474Alpine StirrupsQfixOWB2025-07-09
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02