Cleared Special

K053346 - MODIFICATION TO: DP-9900 DIGITAL ULTRAS...

K053346 is the FDA 510(k) clearance for MODIFICATION TO: DP-9900 DIGITAL ULTRAS... by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Special 510(k) pathway after a 7-day FDA review.

K053346 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
7d
Days
Class 2
Risk

K053346 is an FDA 510(k) clearance for the MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL .... Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on December 9, 2005 after a review of 7 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K053346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2005
Decision Date December 09, 2005
Days to Decision 7 days
Submission Type Special
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
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 387
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K053346.
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
K060483 · Volcano Corporation · Jun 2006
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K061189 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2006
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K060949 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · Volcano Corporation · Dec 2005
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
K051920 · Volcano Corporation · Aug 2005
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K052113 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2005