Cleared Traditional

K874922 - ACUSON TRANSPERINEAL NEEDLE GUIDE

K874922 is an FDA 510(k) clearance for ACUSON TRANSPERINEAL NEEDLE GUIDE, manufactured by Acuson Computed Sonography. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K874922 · Acuson Computed Sonography · Radiology device
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Feb 1988
Decision
78d
Days
Class 2
Risk

K874922 is an FDA 510(k) clearance for the ACUSON TRANSPERINEAL NEEDLE GUIDE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acuson Computed Sonography devices

FDA 510(k) Submission Details - K874922

510(k) Number K874922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1987
Decision Date February 19, 1988
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K874922.
EUP-C321 5.0MHZ CONVEX TYPE PROBE
K890532 · Hitachi Medical Corp. of America · Apr 1990
SIEMENS ENDO-P-PROBE
K897098 · Siemens Medical Solutions USA, Inc. · Feb 1990
RADIUS CF
K894547 · General Electric Co. · Nov 1989
ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
K874860 · Acuson Computed Sonography · Feb 1988
EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX
K870899 · Biosound, Inc. · Dec 1987
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · Diasonics, Inc. · Sep 1987