Cleared Traditional

K910838 - TREATMENT TABLE

K910838 is an FDA 510(k) clearance for TREATMENT TABLE, 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 161-day FDA review.

K910838 · Tri W-G, Inc. · Radiology device
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Aug 1991
Decision
161d
Days
Class 2
Risk

K910838 is an FDA 510(k) clearance for the TREATMENT TABLE. 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 August 7, 1991 after a review of 161 days - an extended review 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: 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

FDA 510(k) Submission Details - K910838

510(k) Number K910838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date August 07, 1991
Days to Decision 161 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
54d slower than avg
Panel avg: 107d · This submission: 161d
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 K910838.
X-RAY TABLE
K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991
ELITE R 90/15
K912741 · Fischer Imaging Corp. · Oct 1991
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
K913147 · Shimadzu Medical Systems · Sep 1991
TANGENT IV
K912586 · Fischer Imaging Corp. · Aug 1991
PHILIPS URO DIAGNOST MRF
K911098 · Philips Medical Systems, Inc. · Jul 1991
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · Tri W-G, Inc. · Apr 1991