Cleared Traditional

K911267 - RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004

K911267 is an FDA 510(k) clearance for RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004, manufactured by Tri W-G, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K911267 · Tri W-G, Inc. · Radiology device
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Apr 1991
Decision
23d
Days
Class 2
Risk

K911267 is an FDA 510(k) clearance for the RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Tri W-G, Inc. devices

FDA 510(k) Submission Details - K911267

510(k) Number K911267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date April 03, 1991
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 36
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K911267.
TREATMENT TABLE
K910838 · Tri W-G, Inc. · Aug 1991
TANGENT IV
K912586 · Fischer Imaging Corp. · Aug 1991
PHILIPS URO DIAGNOST MRF
K911098 · Philips Medical Systems, Inc. · Jul 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · Tri W-G, Inc. · Jan 1991
ELITE 5000
K905501 · Fischer Imaging Corp. · Jan 1991
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K905152 · Shimadzu Medical Systems · Dec 1990