510(k) Report

FDA product code · Radiology

C-Arm Fluoroscopic X-Ray System

RCCClass II21 CFR 892.1650510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, radiology panel

Twenty years of RCC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · RCC

FDA has decided no RCC device since 2007.

Median 510(k) review, days · RCC

Too few RCC 510(k)s in any year since 2007 to give a median.

Recalls per year · RCC

No recall names RCC since 2007.

Adverse event reports per year · RCC

2in 2025

2016: 12017: 222018: 502023: 12025: 2
2007high 50 (2018) · low 0 (2007)2025

MAUDE reports naming product code RCC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—022
20180—050
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—02
20260—0—
FIG. 1 — RCC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in RCC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 892.1650.