Cleared Traditional

K053154 - MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM

K053154 is an FDA 510(k) clearance for MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM, manufactured by Pie Medical. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K053154 · Pie Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
32d
Days
Class 2
Risk

K053154 is an FDA 510(k) clearance for the MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM. 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 Pie Medical (Indianpolis, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 32 days - a notably fast clearance cycle.

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: 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 Pie Medical devices

FDA 510(k) Submission Details - K053154

510(k) Number K053154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date December 16, 2005
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 983
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K053154.
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
K060087 · Medison Co., Ltd. · Jan 2006
ALOKA SD-3500 ULTRASOUND SYSTEM
K060059 · Aloka Co., Ltd. · Jan 2006
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
K053530 · Medison Co., Ltd. · Jan 2006
GE VOLUSON I
K053435 · General Electric Co. · Dec 2005
SONOLINE G60 S ULTRASOUND SYSTEM
K052894 · Siemens Medical Solutions USA, Inc. · Nov 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K053069 · Sonosite,Inc. · Nov 2005