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C015

FDA UDI

Class II (US FDA UDI)

by Micronica Srl

Identity

Trade Name
C015 FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images FDA UDI
Model / Reference
FP XS C015 FDA UDI
Description
Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images FDA UDI

Identifiers

Primary DI / UDI-DI
08053470960000 FDA UDI
510(k) Number
K192182 FDA UDI
FDA Product Code
OWB FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

C015 by Micronica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Cleared under the same submission

K192182 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micronica Srl

Sources (1)

  • FDA UDI 4eb80411-2429-4aac-af15-dbe2b69e6122 34 fields · synced Jun 8, 2026