Cleared Traditional

K110673 - HI VISION ASCENDUS DIAGNOSTIC ULTRASOUN...

K110673 is the FDA 510(k) clearance for HI VISION ASCENDUS DIAGNOSTIC ULTRASOUN... by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K110673 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
202d
Days
Class 2
Risk

K110673 is an FDA 510(k) clearance for the HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER. 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 Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on September 27, 2011 after a review of 202 days - an extended review 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: 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.

View all Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K110673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2011
Decision Date September 27, 2011
Days to Decision 202 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
95d slower than avg
Panel avg: 107d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K110673.
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K113647 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2011
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K112646 · Samsung Medison Co., Ltd. · Oct 2011
APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K110870 · Toshiba America Medical Systems, In.C · Oct 2011
LOGIQ P3
K112371 · Ge Healthcare · Sep 2011
VENUE 40
K112122 · Ge Healthcare · Sep 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213 · Ge Healthcare · Sep 2011