Cleared Traditional

K002880 - 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC

K002880 is an FDA 510(k) clearance for 300LC ULTRASOUND IMAGING SYSTEMS, manufactured by Pie Medical. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K002880 · Pie Medical · Radiology device
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Oct 2000
Decision
41d
Days
Class 2
Risk

K002880 is an FDA 510(k) clearance for the 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC. 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 Pie Medical (Indianpolis, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 41 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 Pie Medical devices

FDA 510(k) Submission Details - K002880

510(k) Number K002880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date October 26, 2000
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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