Cleared Traditional

K151709 - Hi-Light Diagnostic Ultrasound Systems

K151709 is an FDA 510(k) clearance for Hi-Light Diagnostic Ultrasound Systems, manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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

FDA 510(k) Submission Details - K151709

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.

IYO Device Classification - Class 2, Special Controls

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 448
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