Cleared Traditional

K081802 - CX50 DIAGNOSTIC ULTRASOUND SYSTEM

K081802 is an FDA 510(k) clearance for CX50 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Philips Ultrasound, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K081802 · Philips Ultrasound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
15d
Days
Class 2
Risk

K081802 is an FDA 510(k) clearance for the CX50 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Philips Ultrasound, Inc. (Bothell, US). The FDA issued a Cleared decision on July 11, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Philips Ultrasound, Inc. devices

FDA 510(k) Submission Details - K081802

510(k) Number K081802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2008
Decision Date July 11, 2008
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.

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 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 - ITX Transducer, Ultrasonic, Diagnostic

All 223
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K081802.
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
K090912 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2009
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
K083877 · Neusoft Medical Systems Co., Ltd. · Jan 2009
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K082224 · Shimadzu Medical Systems · Dec 2008
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · Boston Scientific Corp · Mar 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · Boston Scientific Corp · Mar 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
K071287 · Shimadzu Medical Systems · Jan 2008