C015

Basic Information

• Brand Name: C015
• Primary DI: 08053470960017
• Version / Model: FP XL C015
• Company Name: MICRONICA SRL
• Labeler DUNS: 428699566
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 1
• Public Version Date: 2020-03-24
• Public Version Status: New
• Public Device Record Key: 672b015a-915c-42ef-bfde-14eda41e1a63

Device Description

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40935	Diagnostic x-ray digital imaging system workstation	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08053470960017	GS1

Premarket Submissions

Submission Number	Supplement Number
K192182	000