Cleared Traditional

K050326 - 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350

K050326 is an FDA 510(k) clearance for 7350 ULTRASOUND IMAGING SYSTEM, manufactured by Esaote, S.P.A.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K050326 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
19d
Days
Class 2
Risk

K050326 is an FDA 510(k) clearance for the 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350. 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 Esaote, S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 19 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 Esaote, S.P.A. devices

FDA 510(k) Submission Details - K050326

510(k) Number K050326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date February 28, 2005
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 1106
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K050326.
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · Siemens Medical Solutions USA, Inc. · May 2005
DOPPLER-BOX
K051085 · Compumedics Germany Gmgh · May 2005
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K050510 · Shimadzu Medical Systems · Apr 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · Toshiba America Medical Systems, In.C · Feb 2005
FUKUDA DENSHI MODEL UF-850XTD
K050363 · Fukuda Denshi USA, Inc. · Feb 2005
USCOM 1A
K043139 · Uscom, Ltd. · Feb 2005