Cleared Traditional

K904722 - FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TAB (FDA 510(k) Clearance)

K904722 · Tri W-G, Inc. · Radiology device
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Jan 1991
Decision
97d
Days
-
Risk

K904722 is an FDA 510(k) clearance for the FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TAB.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on January 23, 1991 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. 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 Tri W-G, Inc. devices

Submission Details

510(k) Number K904722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date January 23, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -