Cleared Traditional

K905535 - ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER

K905535 is an FDA 510(k) clearance for ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K905535 · Ge Medical Systems Information Technologies · Radiology device
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Feb 1991
Decision
80d
Days
Class 2
Risk

K905535 is an FDA 510(k) clearance for the ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on February 28, 1991 after a review of 80 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K905535

510(k) Number K905535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1990
Decision Date February 28, 1991
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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
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