Cleared Traditional

K926258 - DLX

K926258 is an FDA 510(k) clearance for DLX, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K926258 · GE Medical Systems · Radiology device
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Mar 1993
Decision
87d
Days
Class 2
Risk

K926258 is an FDA 510(k) clearance for the DLX. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on March 15, 1993 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 GE Medical Systems devices

FDA 510(k) Submission Details - K926258

510(k) Number K926258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date March 15, 1993
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 114
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K926258.
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664 · Siemens Gammasonics, Inc. · Dec 1993
MULTI-VIEW PROCESSOR (MVP)
K931184 · Adac Laboratories · Nov 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993
ANCOR
K924719 · Siemens Medical Solutions USA, Inc. · Dec 1992
CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
K924137 · Fischer Imaging Corp. · Dec 1992
ANGIOGRAPHIC X-RAY SYSTEM
K922222 · Siemens Medical Solutions USA, Inc. · Dec 1992