Cleared Traditional

K082098 - SONOSITE MAXX SERIES ULTRASOUND SYSTEM

K082098 is an FDA 510(k) clearance for SONOSITE MAXX SERIES ULTRASOUND SYSTEM, manufactured by Sonosite,Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K082098 · Sonosite,Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
31d
Days
Class 2
Risk

K082098 is an FDA 510(k) clearance for the SONOSITE MAXX SERIES 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 Sonosite,Inc. (Bothell, US). The FDA issued a Cleared decision on August 25, 2008 after a review of 31 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 Sonosite,Inc. devices

FDA 510(k) Submission Details - K082098

510(k) Number K082098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date August 25, 2008
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K082098.
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656 · Fukuda Denshi USA, Inc. · Sep 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · Esaote, S.P.A. · Sep 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · Toshiba America Medical Systems, In.C · Aug 2008
GE VIVID E9 ULTRASOUND
K081921 · General Electric Co. · Aug 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794 · Esaote, S.P.A. · Jul 2008