Cleared Traditional

K080049 - VASCUVIEW ULTRASOUND SYSTEM

K080049 is an FDA 510(k) clearance for VASCUVIEW ULTRASOUND SYSTEM, manufactured by Escalon Medical Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K080049 · Escalon Medical Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
15d
Days
Class 2
Risk

K080049 is an FDA 510(k) clearance for the VASCUVIEW ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Escalon Medical Corp. (New Berlin, US). The FDA issued a Cleared decision on January 23, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 - K080049

510(k) Number K080049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2008
Decision Date January 23, 2008
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.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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

Regulatory Technology Services, LLC
MARK JOB

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 849
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K080049.
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
K081154 · B-K Medical Aps · May 2008
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
K081110 · Shantou Institute of Ultrasonic Instuments · May 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · Teratech Corp. · Feb 2008
MASTER-VU
K073196 · Sonomed, Inc. · Dec 2007
ACUSON X300 ULTRASOUND SYSTEM
K072676 · Siemens Medical Solutions USA, Inc. · Dec 2007
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
K072797 · General Electric Co. · Oct 2007
K080049 · VASCUVIEW ULTRASOUND SYSTEM
Download PDF FDA Summary Escalon Medical Corp.