Cleared Traditional

UROLOGICAL C-ARM TABLE, MODEL #056-450 (K922591) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 11
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K922591.
MOBILIX MOBILE X-RAY TABLE
K945842 · GE Medical Systems · 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
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
K922364 · Toshiba America Medical Systems, In.C · Sep 1992
X-RAY TABLE
K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · General Electric Co. · May 1988