RCCClass II
C-arm Fluoroscopic X-ray System
Radiology · 21 CFR 892.1650
Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
MDR events76All time
Recalls1All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
76 adverse event reports on file
- FLOUROSCOPIC SYSTEMJul 7, 2025MalfunctionUnknownMW5172283
- C-ARM IMAGING SYSTEMSJul 2, 2025MalfunctionUnkMW5172182
- Unnamed deviceOct 16, 2023No answer providedCOR23000193-000
- Unnamed deviceAug 10, 2018No answer providedCOR18001175-001
- Unnamed deviceAug 10, 2018No answer providedCOR18001349-000
- Unnamed deviceAug 10, 2018No answer providedCOR18001042-001
- Unnamed deviceAug 10, 2018No answer providedCOR18001044-001
- Unnamed deviceAug 10, 2018No answer providedCOR18001129-001
- Unnamed deviceAug 10, 2018No answer providedCOR18001176-001
- Unnamed deviceJul 30, 2018No answer providedCOR18001301-000
Event type breakdown
No answer provided73
Malfunction2
Other1
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.