Cleared Traditional

K110870 - APLIO DIAGNOSTIC ULTRASOUND SYSTEM

Also marketed or referenced as:
APLIO DIAGNOSTIC ULTRASOUND SYSTEM APLIO DIAGNOSTIC ULTRASOUND SYSTEM

K110870 is the FDA 510(k) clearance for APLIO DIAGNOSTIC ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K110870 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
189d
Days
Class 2
Risk

K110870 is an FDA 510(k) clearance for the APLIO DIAGNOSTIC 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 Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 4, 2011 after a review of 189 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K110870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2011
Decision Date October 04, 2011
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
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 K110870.
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · Ge Healthcare · Dec 2011
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
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · Hitachi Medical Systems America, Inc. · Sep 2011
LOGIQ P3
K112371 · Ge Healthcare · Sep 2011
VENUE 40
K112122 · Ge Healthcare · Sep 2011