Cleared Traditional

K914348 - ER-1000 CATHERIZATION C-ARM SYSTEMS

K914348 is an FDA 510(k) clearance for ER-1000 CATHERIZATION C-ARM SYSTEMS, manufactured by Shimadzu Medical Systems. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K914348 · Shimadzu Medical Systems · Radiology device
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Nov 1991
Decision
35d
Days
Class 1
Risk

K914348 is an FDA 510(k) clearance for the ER-1000 CATHERIZATION C-ARM SYSTEMS. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Medical Systems devices

FDA 510(k) Submission Details - K914348

510(k) Number K914348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date November 01, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYB Tube Mount, X-ray, Diagnostic

All 20
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K914348.
SHIMADZU X-RAY TUBE STAND BH-100 SERIES
K925170 · Shimadzu Medical Systems · Dec 1992
CEILING TUBE SUPPORT CH-30X
K920727 · Shimadzu Medical Systems · Apr 1992
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
K914944 · Bennett X-Ray Corp. · Dec 1991
INVENTOR RT/EXPLORER TRAUMA UNIT
K911563 · Continental X-Ray Corp. · Oct 1991
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL
K912696 · Bennett X-Ray Corp. · Sep 1991
PFM-90 CEILING TUBE SUPPORT
K900234 · Fischer Imaging Corp. · Feb 1990