Cleared Traditional

K883664 - LUM VASCULAR PROCEDURE SYSTEM #B5200A

K883664 is the FDA 510(k) clearance for LUM VASCULAR PROCEDURE SYSTEM #B5200A by General Electric Co.. It is a Class 1 Radiology device (product code IYB) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K883664 · General Electric Co. · Radiology device
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Nov 1988
Decision
73d
Days
Class 1
Risk

K883664 is an FDA 510(k) clearance for the LUM VASCULAR PROCEDURE SYSTEM #B5200A. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on November 7, 1988 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Co. devices

Submission Details

510(k) Number K883664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date November 07, 1988
Days to Decision 73 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 12
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K883664.
SHIMADZU X-RAY TUBE STAND FH-31
K895188 · Shimadzu Medical Systems · Sep 1989
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
K893652 · Fischer Imaging Corp. · Jun 1989
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
K893653 · Fischer Imaging Corp. · Jun 1989
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
K880530 · Fischer Imaging Corp. · Mar 1988
OVERHEAD TUBE MOUNT CASCADE II
K880528 · Fischer Imaging Corp. · Feb 1988
AP X-RAY TUBE ANGULATION DEVICE
K811970 · Philips Medical Systems (Cleveland), Inc. · Aug 1981