Cleared Traditional

MULTIPURPOSE TRANSDUCER RANGE (K874192) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874192 · Pie Data Medical BV · Radiology device
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Jul 1988
Decision
279d
Days
Class 2
Risk

K874192 is an FDA 510(k) clearance for the MULTIPURPOSE TRANSDUCER RANGE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Pie Data Medical BV (Maastricht 6227 Aj, NL). The FDA issued a Cleared decision on July 19, 1988 after a review of 279 days - an extended review 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: 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 Data Medical BV devices

Submission Details

510(k) Number K874192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date July 19, 1988
Days to Decision 279 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 107d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K874192.
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MODIFIED MODEL SSD-650 SYSTEM
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ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · Philips Medical Systems (Cleveland), Inc. · May 1988
VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
K872307 · General Electric Co. · Sep 1987
OLYMPUS GF-UM2/EU-M2
K872027 · Olympus Corp. · Aug 1987