Device
This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular,...
Manufacturer
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Model: ARCO FP-Rk0530S
Catalog: 74 10 000-1
DI: 08055186671249
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
729a87a9-fa5e-4244-a7cd-4366be7ab185
Distribution Status:
In Commercial Distribution
DUNS Number:
440069847
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08055186671249
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37646
Name: Mobile general-purpose fluoroscopic x-ray system, digital
Definition:
A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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 both real-time and delayed formats.
FDA Product Codes
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
OWB
Interventional Fluoroscopic X-Ray System
Premarket Submissions
Submission Number:
K182086
Supplement Number:
000