Cleared Traditional

K092858 - SAFERSONIC SONOGRAPHY COVER

K092858 is an FDA 510(k) clearance for SAFERSONIC SONOGRAPHY COVER, manufactured by Safersonic Medizinprodukte GmbH. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K092858 · Safersonic Medizinprodukte GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
55d
Days
Class 2
Risk

K092858 is an FDA 510(k) clearance for the SAFERSONIC SONOGRAPHY COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Safersonic Medizinprodukte GmbH (Greenwood Village, US). The FDA issued a Cleared decision on November 10, 2009 after a review of 55 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. 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 Safersonic Medizinprodukte GmbH devices

FDA 510(k) Submission Details - K092858

510(k) Number K092858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2009
Decision Date November 10, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 281
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K092858.
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K101041 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · Toshiba America Medical Systems, In.C · Jan 2010
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K093714 · Medison Co., Ltd. · Dec 2009
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K092691 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2009
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K091804 · Philips Ultrasound, Inc. · Jul 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K091941 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2009