Cleared Traditional

K811195 - ARGOSTAT

K811195 is an FDA 510(k) clearance for ARGOSTAT, manufactured by Tecnomed, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K811195 · Tecnomed, Inc. · Radiology device
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Jun 1981
Decision
40d
Days
Class 1
Risk

K811195 is an FDA 510(k) clearance for the ARGOSTAT. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Tecnomed, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 40 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 Tecnomed, Inc. devices

FDA 510(k) Submission Details - K811195

510(k) Number K811195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1981
Decision Date June 09, 1981
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
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 19
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K811195.
OVERHEAD TUBE MOUNT CASCADE II
K880528 · Fischer Imaging Corp. · Feb 1988
TRAUMA STAND
K852952 · Xre Corp. · Sep 1985
AP X-RAY TUBE ANGULATION DEVICE
K811970 · Philips Medical Systems (Cleveland), Inc. · Aug 1981
X-RAY STAND & OPERATING CHAIR
K803162 · Downs Surgical , Ltd. · Jan 1981
L/U ARM-VASCULAR
K781571 · General Electric Co. · Nov 1978
PLURIMAT
K781065 · Tecnomed, Inc. · Jul 1978