Cleared Traditional

K904540 - VIDEO SYSTEM INTERFACE MODELS

K904540 is the FDA 510(k) clearance for VIDEO SYSTEM INTERFACE MODELS by Perkins Mfg. Co.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K904540 · Perkins Mfg. Co. · Radiology device
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Oct 1990
Decision
22d
Days
Class 2
Risk

K904540 is an FDA 510(k) clearance for the VIDEO SYSTEM INTERFACE MODELS. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Perkins Mfg. Co. (Dallas, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 22 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 Perkins Mfg. Co. devices

Submission Details

510(k) Number K904540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date October 26, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 100
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K904540.
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
K903371 · Shimadzu Medical Systems · Nov 1990
CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
K903372 · Shimadzu Medical Systems · Nov 1990
CATHETERIZATION C-ARM SUPPORT MH-51C(F)
K903373 · Shimadzu Medical Systems · Nov 1990
HICOR
K903375 · Siemens Gammasonics, Inc. · Oct 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542 · Philips Medical Systems North America, Inc. · Aug 1990
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · Toshiba America Medical Systems, In.C · Mar 1990