Cleared Traditional

Hi-Light Diagnostic Ultrasound Systems (K151709) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151709 · Qingdao Hisense Medical Equipment Co., Ltd. · Radiology device
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Jul 2015
Decision
23d
Days
Class 2
Risk

K151709 is an FDA 510(k) clearance for the Hi-Light Diagnostic Ultrasound Systems. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Qingdao Hisense Medical Equipment Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on July 17, 2015 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Qingdao Hisense Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K151709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date July 17, 2015
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 213
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K151709.
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
K171528 · Avantsonic Technology Co., Ltd. · Jan 2018
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
K171824 · Edan Instruments, Inc. · Jul 2017
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
K152554 · C.R. Bard, Inc. · Dec 2015
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · C.R. Bard, Inc. · Mar 2015
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · C.R. Bard, Inc. · Oct 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · Siemens Medical Solutions USA, Inc. · Sep 2014