Cleared Traditional

K942441 - IMEXDOP CT+

K942441 is an FDA 510(k) clearance for IMEXDOP CT+, manufactured by Imex Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K942441 · Imex Medical Systems, Inc. · Radiology device
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Aug 1994
Decision
92d
Days
Class 2
Risk

K942441 is an FDA 510(k) clearance for the IMEXDOP CT+. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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 Imex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K942441

510(k) Number K942441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1994
Decision Date August 23, 1994
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 - JAF Monitor, Ultrasonic, Nonfetal

All 11
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K942441.
IMEX STETHODOP
K973336 · Imex Medical Systems, Inc. · Feb 1998
IMWXDOP IR
K944196 · Imex Medical Systems, Inc. · May 1995
R AND D BATTERIES
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MULTI DOPPLEX, MD-1
K900882 · Huntleigh Technology, Inc. · Aug 1990
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · Philips Medical Systems, Inc. · Apr 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591 · Philips Medical Systems, Inc. · Apr 1986