Cleared Traditional

K903373 - CATHETERIZATION C-ARM SUPPORT MH-51C(F)

K903373 is an FDA 510(k) clearance for CATHETERIZATION C-ARM SUPPORT MH-51C(F), manufactured by Shimadzu Medical Systems. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K903373 · Shimadzu Medical Systems · Radiology device
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Nov 1990
Decision
126d
Days
Class 2
Risk

K903373 is an FDA 510(k) clearance for the CATHETERIZATION C-ARM SUPPORT MH-51C(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

FDA 510(k) Submission Details - K903373

510(k) Number K903373 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
Combination Product No
PCCP Authorized No
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.

IZI Device Classification - Class 2, Special Controls

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 161
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K903373.
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941 · Shimadzu Medical Systems · Feb 1991
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
K903371 · Shimadzu Medical Systems · Nov 1990
CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
K903372 · Shimadzu Medical Systems · Nov 1990
HICOR
K903375 · Siemens Gammasonics, Inc. · Oct 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542 · Philips Medical Systems North America, Inc. · Aug 1990
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · Toshiba America Medical Systems, In.C · Mar 1990