Cleared Traditional

K032135 - SITE-RITE IV ULTRASOUND SYSTEM

K032135 is an FDA 510(k) clearance for SITE-RITE IV ULTRASOUND SYSTEM, manufactured by Dymax Corp. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K032135 · Dymax Corp · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
10d
Days
Class 2
Risk

K032135 is an FDA 510(k) clearance for the SITE-RITE IV ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Dymax Corp (Pittsburgh, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 10 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.

FDA 510(k) Submission Details - K032135

510(k) Number K032135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date July 21, 2003
Days to Decision 10 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
97d faster than avg
Panel avg: 107d · This submission: 10d
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

Citech

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 828
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K032135.
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · Accutome, Inc. · Oct 2003
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
K032875 · Aloka Co. Ltd USA · Sep 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
K032640 · U-Systems, Inc. · Sep 2003
UF BRACHYTHERAPY STAND
K023430 · University of Florida · Jun 2003
HF MODULE WITH TRANSDUCERS
K031391 · Ophthalmic Technologies, Inc. · Jun 2003
OTI SCAN WITH TRANSDUCERS
K030770 · Ophthalmic Technologies, Inc. · Mar 2003
K032135 · SITE-RITE IV ULTRASOUND SYSTEM
Download PDF FDA Summary Dymax Corp