Cleared Traditional

HEMISPHERE MULTIPLANE ENDORECTAL PROBE (K911043) - FDA 510(k) Clearance

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

K911043 · Pie Medical Equipment B.V. · Radiology device
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Oct 1991
Decision
215d
Days
Class 2
Risk

K911043 is an FDA 510(k) clearance for the HEMISPHERE MULTIPLANE ENDORECTAL PROBE. 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 9, 1991 after a review of 215 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

Submission Details

510(k) Number K911043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date October 09, 1991
Days to Decision 215 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 107d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K911043.
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RADIUS AND SONOCHROME
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