Cleared Traditional

K870899 - EZU-PC 2A/5.0 & 3A/3.5MHZ

K870899 is an FDA 510(k) clearance for EZU-PC 2A/5.0 & 3A/3.5MHZ, manufactured by Biosound, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K870899 · Biosound, Inc. · Radiology device
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Dec 1987
Decision
300d
Days
Class 2
Risk

K870899 is an FDA 510(k) clearance for the EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Biosound, Inc. devices

FDA 510(k) Submission Details - K870899

510(k) Number K870899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date December 30, 1987
Days to Decision 300 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 107d · This submission: 300d
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 223
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K870899.
RADIUS CF
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ACUSON TRANSPERINEAL NEEDLE GUIDE
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ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
K874860 · Acuson Computed Sonography · Feb 1988
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · Diasonics, Inc. · Sep 1987
3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW
K871432 · Advanced Technology Laboratories, Inc. · Aug 1987
SONOLAYER - V, SSA-100A.
K863269 · Toshiba Medical Systems · Jul 1987