Cleared Traditional

K042540 - PHILIPS IU22 ULTRASOUND SYSTEM

K042540 is an FDA 510(k) clearance for PHILIPS IU22 ULTRASOUND SYSTEM, manufactured by Philips Ultrasound, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K042540 · Philips Ultrasound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
14d
Days
Class 2
Risk

K042540 is an FDA 510(k) clearance for the PHILIPS IU22 ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Philips Ultrasound, Inc. (Bothell, US). The FDA issued a Cleared decision on October 4, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 - K042540

510(k) Number K042540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date October 04, 2004
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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

Underwriters Laboratories, Inc.

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 448
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K042540.
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · Olympus Medical Systems Corporation · Dec 2004
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
K043078 · Toshiba America Medical Systems, In.C · Nov 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · Siemens Medical Solutions USA, Inc. · Oct 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
K040719 · Aloka Co., Ltd. · Mar 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · Siemens Medical Solutions USA, Inc. · Mar 2004
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
K020668 · Aloka Co., Ltd. · Jul 2002