Cleared Traditional

K973336 - IMEX STETHODOP

K973336 is an FDA 510(k) clearance for IMEX STETHODOP, 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 154-day FDA review.

K973336 · Imex Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
154d
Days
Class 2
Risk

K973336 is an FDA 510(k) clearance for the IMEX STETHODOP. 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 February 5, 1998 after a review of 154 days - an extended review cycle.

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 - K973336

510(k) Number K973336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1997
Decision Date February 05, 1998
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
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 27
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K973336.
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
K052067 · Multigon Industries, Inc. · Aug 2005
NICOLET VERSALAB
K010521 · Nicolet Biomedical · Mar 2001
CAREDOP II
K982635 · Nicolet Biomedical · Aug 1998
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857 · Biomedix, Inc. · Dec 1997
FLOSTAT VASCULAR LAB
K973644 · Biomedix, Inc. · Dec 1997
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
K943338 · Biosensor Corp. · Apr 1996