Cleared Traditional

K120321 - CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM

K120321 is an FDA 510(k) clearance for CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND ..., manufactured by Philips Health Care. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K120321 · Philips Health Care · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
15d
Days
Class 2
Risk

K120321 is an FDA 510(k) clearance for the CLEARVUE 350/550 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 Philips Health Care (Andover, US). The FDA issued a Cleared decision on February 17, 2012 after a review of 15 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 Philips Health Care devices

FDA 510(k) Submission Details - K120321

510(k) Number K120321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2012
Decision Date February 17, 2012
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 1083
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K120321.
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K121010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2012
ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
K120703 · Zonare Medical Systems, Inc. · Apr 2012
E-CUBE 9
K120060 · Alpinion Medical Systems Co., Ltd. · Mar 2012
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
K113612 · Panasonic Healthcare Co., Ltd. · Feb 2012
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
K112953 · Teratech Corp. · Feb 2012
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
K113359 · Chison Medical Imaging Co., Ltd. · Feb 2012