Cleared Traditional

K002357 - 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS

K002357 is an FDA 510(k) clearance for 100 S AND 100 LC AND 485 ANSER ULTRASOU..., 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 99-day FDA review.

K002357 · Pie Medical · Radiology device
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Nov 2000
Decision
99d
Days
Class 2
Risk

K002357 is an FDA 510(k) clearance for the 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS. 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 November 9, 2000 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K002357

510(k) Number K002357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2000
Decision Date November 09, 2000
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 569
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