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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 29
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K941004.
SUPERSTAND 300
K935123 · Wuestec Medical, Inc. · Mar 1996
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
K946261 · Scott Imaging Intl., Inc. · Feb 1995
F/C/W TUBESTAND
K941017 · Acoma Medical Imaging, Inc. · Jul 1994
MPR-814
K940442 · Xri, Inc. · Jun 1994
MODEL ALPHA TS-2
K935004 · Dpa Consulting, Inc. · Dec 1993
SUPERSTAND 3000
K933253 · Wuestec Medical, Inc. · Aug 1993
K941004 · CTS SYSTEM
Download PDF FDA Summary Acoma Medical Imaging…