Cleared Traditional

K003725 - 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS

K003725 is an FDA 510(k) clearance for 240 PARUS ULTRASOUND IMAGING SYSTEMS, manufactured by Pie Medical. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K003725 · Pie Medical · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
87d
Days
Class 2
Risk

K003725 is an FDA 510(k) clearance for the 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Pie Medical (Indianpolis, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 87 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 - K003725

510(k) Number K003725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date March 01, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K003725.
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K003725 · 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
Download PDF FDA Summary Pie Medical