Cleared Traditional

K922591 - UROLOGICAL C-ARM TABLE

K922591 is an FDA 510(k) clearance for UROLOGICAL C-ARM TABLE, manufactured by Biodan Medical Systems, Ltd.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K922591 · Biodan Medical Systems, Ltd. · Radiology device
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Nov 1992
Decision
178d
Days
Class 2
Risk

K922591 is an FDA 510(k) clearance for the UROLOGICAL C-ARM TABLE, MODEL #056-450. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 178 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 Biodan Medical Systems, Ltd. devices

FDA 510(k) Submission Details - K922591

510(k) Number K922591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date November 27, 1992
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
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 37
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K922591.
HYDRADJUST IV UROLOGICAL TABLE
K943581 · Mallinckrodt Group, Inc. · Jan 1995
URO - ELITE TABLE ACCESSORIES
K944987 · Philips Medical Systems (Cleveland), Inc. · Nov 1994
CLINIX VP 4 TABLE
K940721 · Philips Medical Systems (Cleveland), Inc. · May 1994
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
K925175 · Shimadzu Medical Systems · Nov 1992
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
K922364 · Toshiba America Medical Systems, In.C · Sep 1992
UROLOGICAL X-RAY TABLE HS-10A
K920726 · Shimadzu Medical Systems · May 1992