Cleared Traditional

K153421 - HI VISION ASCENDUS

K153421 is an FDA 510(k) clearance for HI VISION ASCENDUS, manufactured by Hitachi Aloka Medical America, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K153421 · Hitachi Aloka Medical America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
57d
Days
Class 2
Risk

K153421 is an FDA 510(k) clearance for the HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS. 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 Aloka Medical America, Inc. (Wallingford, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 57 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 Hitachi Aloka Medical America, Inc. devices

FDA 510(k) Submission Details - K153421

510(k) Number K153421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date January 21, 2016
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
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 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K153421.
LOGIQ S7 Expert
K160182 · Ge Healthcare · Feb 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · Ge Healthcare · Feb 2016
WS80A Diagnostic Ultrasound System
K153529 · Samsung Medison Co., Ltd. · Feb 2016
SonoSite Edge II Ultrasound System
K153626 · FUJIFILM Sonosite, Inc. · Jan 2016
S50 Digital Color Doppler Ultrasound System
K152854 · Sonoscape Medical Corp. · Jan 2016
HM70A Diagnostic Ultrasound System
K153408 · Samsung Medison Co., Ltd. · Dec 2015