Cleared Traditional

K881701 - RADKOR SFC-21

K881701 is an FDA 510(k) clearance for RADKOR SFC-21, manufactured by Radkor, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K881701 · Radkor, Inc. · Radiology device
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Sep 1988
Decision
142d
Days
Class 1
Risk

K881701 is an FDA 510(k) clearance for the RADKOR SFC-21. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Radkor, Inc. (Irvine, US). The FDA issued a Cleared decision on September 8, 1988 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radkor, Inc. devices

FDA 510(k) Submission Details - K881701

510(k) Number K881701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date September 08, 1988
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYB Tube Mount, X-ray, Diagnostic

All 21
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K881701.
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
K893652 · Fischer Imaging Corp. · Jun 1989
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
K893653 · Fischer Imaging Corp. · Jun 1989
LUM VASCULAR PROCEDURE SYSTEM #B5200A
K883664 · General Electric Co. · Nov 1988
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
K880530 · Fischer Imaging Corp. · Mar 1988
OVERHEAD TUBE MOUNT CASCADE II
K880528 · Fischer Imaging Corp. · Feb 1988
TRAUMA STAND
K852952 · Xre Corp. · Sep 1985