Cleared Traditional

K935595 - ACUSON MODEL 3001

K935595 is an FDA 510(k) clearance for ACUSON MODEL 3001, manufactured by Acuson Corp.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K935595 · Acuson Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
468d
Days
Class 2
Risk

K935595 is an FDA 510(k) clearance for the ACUSON MODEL 3001. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 468 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Acuson Corp. devices

FDA 510(k) Submission Details - K935595

510(k) Number K935595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1993
Decision Date March 02, 1995
Days to Decision 468 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
361d slower than avg
Panel avg: 107d · This submission: 468d
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 336
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