Cleared Traditional

K051139 - ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

K051139 is an FDA 510(k) clearance for ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K051139 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
9d
Days
Class 2
Risk

K051139 is an FDA 510(k) clearance for the ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND 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 Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 13, 2005 after a review of 9 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K051139

510(k) Number K051139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date May 13, 2005
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1091
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K051139.
GE VIVID 7 WITH OR WITHOUT SUFFIX
K051449 · GE Medical Systems · Jun 2005
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
K051334 · Teratech Corp. · Jun 2005
MYLAB 70 ULTRASOUND IMAGING SYSTEM
K051308 · Esaote, S.P.A. · Jun 2005
DOPPLER-BOX
K051085 · Compumedics Germany Gmgh · May 2005
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K050510 · Shimadzu Medical Systems · Apr 2005
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
K050326 · Esaote, S.P.A. · Feb 2005