Cleared Traditional

K023024 - TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

K023024 is an FDA 510(k) clearance for TRANSVAGINAL DOPPLER PROBE, manufactured by Vascular Control Systems, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K023024 · Vascular Control Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
15d
Days
Class 2
Risk

K023024 is an FDA 510(k) clearance for the TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 26, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023024

510(k) Number K023024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date September 26, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Consultant

Tuv Rheinland of North America, Inc.
HEINZ JOERG STENBERG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 407
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K023024.
TRANSVAGINAL DOPPLER PROBE
K031358 · Vascular Control Systems, Inc. · May 2003
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · Sonosite,Inc. · Jan 2003
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · Boston Scientific, Target · Nov 2002
COOK-SWARTZ DOPPLER FLOW PROBE
K022649 · Cook Vascular, Inc. · Sep 2002
CROSSPOINT TRANSACCESS CATHETER
K013363 · Trans Vascular Incorporated · Apr 2002
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K013723 · Hitachi Medical Corp. · Feb 2002
K023024 · TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
Download PDF FDA Summary Vascular Control Syst…