Cleared Traditional

K875376 - SHIMADZU CATHETERIZATION C-ARM STAND MH-50B

K875376 is an FDA 510(k) clearance for SHIMADZU CATHETERIZATION C-ARM STAND MH-50B, manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K875376 · Shimadzu Precision Instruments, Inc. · Radiology device
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Feb 1988
Decision
43d
Days
Class 2
Risk

K875376 is an FDA 510(k) clearance for the SHIMADZU CATHETERIZATION C-ARM STAND MH-50B. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on February 12, 1988 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shimadzu Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K875376

510(k) Number K875376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date February 12, 1988
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
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 114
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K875376.
C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20
K875373 · Shimadzu Precision Instruments, Inc. · Feb 1988
SHIMADZU CEILING-SUSPENDED C-ARM CH-50
K875374 · Shimadzu Precision Instruments, Inc. · Feb 1988
SHIMADZU LATERAL C-ARM MH-30
K875375 · Shimadzu Precision Instruments, Inc. · Feb 1988
SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A
K875379 · Shimadzu Precision Instruments, Inc. · Feb 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-10
K875380 · Shimadzu Precision Instruments, Inc. · Feb 1988
ISOREX LS-36
K834496 · Elscint, Inc. · Feb 1984