Cleared Traditional

K003525 - VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

K003525 is an FDA 510(k) clearance for VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Medison America, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K003525 · Medison America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
7d
Days
Class 2
Risk

K003525 is an FDA 510(k) clearance for the VOLUSON 730 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 Medison America, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 7 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 Medison America, Inc. devices

FDA 510(k) Submission Details - K003525

510(k) Number K003525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2000
Decision Date November 22, 2000
Days to Decision 7 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
100d faster than avg
Panel avg: 107d · This submission: 7d
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

Tuv Product Service, Inc.
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 918
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K003525.
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · Shimadzu Medical Systems · Feb 2001
VIVID 7 WITH SONOPAC, MODEL FB0008XX
K003931 · Ge Medical Systems, Inc. · Jan 2001
ALOKA SSD-4000
K003739 · Aloka Co., Ltd. · Dec 2000
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K003399 · Sonosite,Inc. · Nov 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · Siemens Medical Solutions USA, Inc. · Oct 2000
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
K002470 · Agilent Technologies, Inc. · Sep 2000