Cleared Traditional

VASCUVIEW TAP ULTRASOUND SYSTEM (K093613) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093613 · Escalon Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
30d
Days
Class 2
Risk

K093613 is an FDA 510(k) clearance for the VASCUVIEW TAP ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Escalon Medical Corp. (New Berlin, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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.

View all Escalon Medical Corp. devices

Submission Details

510(k) Number K093613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date December 23, 2009
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 579
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K093613.
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · Siemens Medical Solutions USA, Inc. · Sep 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · Ge Healthcare · Aug 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · Siemens Medical Solutions USA, Inc. · Mar 2010
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271 · Ge Healthcare · Nov 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · Siemens Medical Solutions USA, Inc. · Mar 2009
GE VIVID E9 ULTRASOUND
K081921 · General Electric Co. · Aug 2008