Cleared Traditional

K941004 - CTS SYSTEM

K941004 is an FDA 510(k) clearance for CTS SYSTEM, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K941004 · Acoma Medical Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
150d
Days
Class 1
Risk

K941004 is an FDA 510(k) clearance for the CTS SYSTEM. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 150 days - an extended review 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: 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 Acoma Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K941004

510(k) Number K941004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date July 29, 1994
Days to Decision 150 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 107d · This submission: 150d
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 K941004.
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
K925716 · Bennett X-Ray Corp. · Dec 1992
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
ER-1000 CATHERIZATION C-ARM SYSTEMS
K914348 · Shimadzu Medical Systems · Nov 1991
INVENTOR RT/EXPLORER TRAUMA UNIT
K911563 · Continental X-Ray Corp. · Oct 1991