Cleared Traditional

CATHETERIZATION C-ARM SUPPORT MH-51B(F) (K903371) - FDA 510(k) Clearance

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

K903371 · Shimadzu Medical Systems · Radiology device
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Nov 1990
Decision
126d
Days
Class 2
Risk

K903371 is an FDA 510(k) clearance for the CATHETERIZATION C-ARM SUPPORT MH-51B(F). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K903371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1990
Decision Date November 29, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 46
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K903371.
DXS DIGITAL X-RAY SUBTRACTION
K914376 · Philips Medical Systems (Cleveland), Inc. · Feb 1992
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · Siemens Medical Solutions USA, Inc. · Aug 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · GE Medical Systems · May 1991
LC, CARDIAC POSITIONER #B5078A
K890348 · General Electric Co. · Feb 1989
MULTISKOP
K890352 · Siemens Medical Solutions USA, Inc. · Feb 1989
ANGIOSTAR
K884912 · Siemens Medical Solutions USA, Inc. · Feb 1989