Cleared Traditional

K192152 - DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/...

K192152 is the FDA 510(k) clearance for DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/... by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K192152 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
126d
Days
Class 2
Risk

K192152 is an FDA 510(k) clearance for the DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnos.... 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 13, 2019 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K192152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date December 13, 2019
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K192152.
VINNO 8, VINNO 6, VINNO 5
K190120 · Vinno Technology (Suzhou) Co.,Ltd · Jan 2020
RS85 Diagnostic Ultrasound System
K192903 · Samsung Medison Co., Ltd. · Jan 2020
ZS3 and z.one pro Ultrasound Systems
K192410 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2019
HS50/HS60 Diagnostics Ultrasound System
K192505 · Samsung Medison Co., Ltd. · Dec 2019
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
K192319 · Samsung Medison Co., Ltd. · Dec 2019
6450 Ultrasound system
K192157 · Esaote, S.P.A. · Nov 2019