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510(k) Data Aggregation
K Number
K192182Device Name
C015
Manufacturer
Micronica SRL
Date Cleared
2020-01-17
(158 days)
Product Code
OWB, JAA, LMC, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Micronica SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C015 device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device.
The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures.
- Applications:
- Orthopedic
- Neuro
- Abdominal
- Vascular
- Thoracic
- Cardiac
The device is intended to be used and operated by adequately tramed, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
Device Description
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