Cleared Traditional

K884292 - STRETCHER TABLE

K884292 is an FDA 510(k) clearance for STRETCHER TABLE, manufactured by Fischer Imaging Corp.. The device is a Class 1 Radiology device with product code KXH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K884292 · Fischer Imaging Corp. · Radiology device
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Mar 1989
Decision
170d
Days
Class 1
Risk

K884292 is an FDA 510(k) clearance for the STRETCHER TABLE. Classified as Cradle, Patient, Radiologic (product code KXH), Class I - General Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on March 31, 1989 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1830 - 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 Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K884292

510(k) Number K884292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date March 31, 1989
Days to Decision 170 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
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

KXH Device Classification - Class 1, General Controls

Product Code KXH Cradle, Patient, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1830
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.