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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 716
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K151709.
iLab Ultrasound Imaging System
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