Cleared Traditional

K060064 - STETHOFLUX

K060064 is an FDA 510(k) clearance for STETHOFLUX, manufactured by Odvi. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K060064 · Odvi · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
91d
Days
Class 2
Risk

K060064 is an FDA 510(k) clearance for the STETHOFLUX. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Odvi (Orsay, FR). The FDA issued a Cleared decision on April 10, 2006 after a review of 91 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.

FDA 510(k) Submission Details - K060064

510(k) Number K060064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2006
Decision Date April 10, 2006
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 31
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K060064.
THD SLIDE
K081429 · Thd Spa · Jul 2008
THD
K070815 · G.F. S.R.L. · Jun 2007
VISTA AVS
K063600 · Summit Doppler Systems, Inc. · Dec 2006
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
K060064 · STETHOFLUX
Download PDF FDA Summary Odvi