Cleared Traditional

K161843 - Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

K161843 is an FDA 510(k) clearance for Aplio i900/i800/i700 Diagnostic Ultraso..., manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K161843 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
78d
Days
Class 2
Risk

K161843 is an FDA 510(k) clearance for the Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0. 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 Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on September 21, 2016 after a review of 78 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 Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K161843

510(k) Number K161843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date September 21, 2016
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 Consultant

Toshiba America Medical Systems, In.C
ORLANDO TADEO

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1097
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161843.
Xario 100 Diagnostic Ultrasound System, V5.0
K162187 · Toshibamedical Systems Corporation · Sep 2016
Acuson Freestyle Ultrasound System
K162417 · Siemens Medi Cal Solutions, Inc. · Sep 2016
E-CUBE 11
K161439 · Alpinion Medical Systems Co., Ltd. · Sep 2016
EBit Series Diagnostic Ultrasound System
K162172 · Chison Medical Imaging Co., Ltd. · Sep 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · Philips Health Care · Sep 2016
SonoSite iViz Ultrasound System
K162288 · FUJIFILM Sonosite, Inc. · Sep 2016