Cleared Traditional

K014191 - M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540

K014191 is an FDA 510(k) clearance for M2540 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Philips Medical Systems. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K014191 · Philips Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
17d
Days
Class 2
Risk

K014191 is an FDA 510(k) clearance for the M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540. 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 Medical Systems (Andover, US). The FDA issued a Cleared decision on January 7, 2002 after a review of 17 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 Medical Systems devices

FDA 510(k) Submission Details - K014191

510(k) Number K014191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date January 07, 2002
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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 1117
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K014191.
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · Siemens Medical Systems, Inc. · Feb 2002
LOGIQ 3
K020263 · General Electric Co. · Feb 2002
GE LOGIQ 5
K014097 · GE Medical Systems · Jan 2002
HAND-CARRIED ULTRASOUND SYSTEM
K014116 · Sonosite,Inc. · Dec 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · Medison America, Inc. · Nov 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · Medison America, Inc. · Sep 2001