Cleared Traditional

K914348 - ER-1000 CATHERIZATION C-ARM SYSTEMS

K914348 is the FDA 510(k) clearance for ER-1000 CATHERIZATION C-ARM SYSTEMS by Shimadzu Medical Systems. It is a Class 1 Radiology device (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

Submission Details

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.

Device Classification

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 12
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
PFM-90 CEILING TUBE SUPPORT
K900234 · Fischer Imaging Corp. · Feb 1990
SHIMADZU X-RAY TUBE STAND FH-31
K895188 · Shimadzu Medical Systems · Sep 1989
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
K893652 · Fischer Imaging Corp. · Jun 1989
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
K893653 · Fischer Imaging Corp. · Jun 1989