Cleared Traditional

K911044 - 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

K911044 is an FDA 510(k) clearance for 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04..., manufactured by Pie Medical Equipment B.V.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K911044 · Pie Medical Equipment B.V. · Radiology device
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Oct 1991
Decision
213d
Days
Class 2
Risk

K911044 is an FDA 510(k) clearance for the 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Pie Medical Equipment B.V. (Maastricht, NL). The FDA issued a Cleared decision on October 7, 1991 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 - K911044

510(k) Number K911044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date October 07, 1991
Days to Decision 213 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 305
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K911044.
SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM
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BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · Biosound, Inc. · Dec 1991
ACUSON V510 TRANSDUCER
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CVIS INSIGHT IMAGING CATHETERS
K911414 · Cardiovascular Imaging Systems, Inc. · Sep 1991
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3
K912363 · Hitachi Medical Corp. of America · Aug 1991
CW DOPPLER/4.5 MHZ
K903984 · Diasonics, Inc. · Jun 1991