Cleared Traditional

CEILING SUSPENDED C-ARM SUPPORT MH-100 (K943545) - FDA 510(k) Clearance

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

K943545 · Shimadzu Medical Systems · Radiology device
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Feb 1995
Decision
197d
Days
Class 2
Risk

K943545 is an FDA 510(k) clearance for the CEILING SUSPENDED C-ARM SUPPORT MH-100. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 197 days - an extended review cycle.

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 K943545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date February 03, 1995
Days to Decision 197 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
90d slower than avg
Panel avg: 107d · This submission: 197d
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 K943545.
DIGITAL IMAGING SYSTEM (BSR)
K991922 · Siemens Medical Solutions USA, Inc. · Sep 1999
ADVANTX LCN, ADVANTX LCLP
K974367 · GE Medical Systems · Feb 1998
ADVANTX LCV+
K960575 · GE Medical Systems · May 1996
ADVANTX LCA
K945375 · GE Medical Systems · Jan 1995
DLX
K945459 · General Electric Co. · Jan 1995
TOP ACOM STATION
K945293 · Siemens Medical Solutions USA, Inc. · Jan 1995