Cleared Traditional

K922364 - DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST

K922364 is an FDA 510(k) clearance for DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC..., manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K922364 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 1992
Decision
108d
Days
Class 2
Risk

K922364 is an FDA 510(k) clearance for the DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 108 days - within the typical 510(k) review window.

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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K922364

510(k) Number K922364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date September 04, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
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 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K922364.
CLINIX VP 4 TABLE
K940721 · Philips Medical Systems (Cleveland), Inc. · May 1994
UROLOGICAL C-ARM TABLE, MODEL #056-450
K922591 · Biodan Medical Systems, Ltd. · Nov 1992
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
K925175 · Shimadzu Medical Systems · Nov 1992
UROLOGICAL X-RAY TABLE HS-10A
K920726 · Shimadzu Medical Systems · May 1992
X-RAY DIAGNOSTIC TABLE YSF-100
K920728 · Shimadzu Medical Systems · May 1992
HYDRAJUST IV UROLOGICAL TABLE
K920742 · Mallinckrodt Group, Inc. · Apr 1992