Cleared Traditional

K912819 - SC1150 CW/PD

K912819 is an FDA 510(k) clearance for SC1150 CW/PD, manufactured by Pie Medical Equipment B.V.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K912819 · Pie Medical Equipment B.V. · Radiology device
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Jan 1992
Decision
198d
Days
Class 2
Risk

K912819 is an FDA 510(k) clearance for the SC1150 CW/PD. 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 Equipment B.V. (Maastricht, NL). The FDA issued a Cleared decision on January 9, 1992 after a review of 198 days - an extended review 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: 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.

View all Pie Medical Equipment B.V. devices

FDA 510(k) Submission Details - K912819

510(k) Number K912819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date January 09, 1992
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
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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