Cleared Special

K052021 - V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER

K052021 is an FDA 510(k) clearance for V5MS TRANSDUCER AND MPT7-4 MULTIPLANE T..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 22-day FDA review.

K052021 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
22d
Days
Class 2
Risk

K052021 is an FDA 510(k) clearance for the V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 17, 2005 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K052021

510(k) Number K052021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date August 17, 2005
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 325
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K052021.
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
K060947 · Boston Scientific Corp · Apr 2006
AIM ACCURACY IN MARKING SYSTEM
K053463 · Georgene Austria · Mar 2006
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · C.R. Bard, Inc. · Sep 2005
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
K050320 · Ascendia Medtech AB · Aug 2005
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
K050724 · C.R. Bard, Inc. · Apr 2005
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
K043425 · Sheathing Technologies, Inc. · Feb 2005