Cleared Traditional

K852974 - ACUSON RADIOLOGY DOPPLER ACCESSORY

K852974 is an FDA 510(k) clearance for ACUSON RADIOLOGY DOPPLER ACCESSORY, 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 101-day FDA review.

K852974 · Acuson Computed Sonography · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
101d
Days
Class 2
Risk

K852974 is an FDA 510(k) clearance for the ACUSON RADIOLOGY DOPPLER ACCESSORY. 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 October 24, 1985 after a review of 101 days - within the typical 510(k) review window.

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 Acuson Computed Sonography devices

FDA 510(k) Submission Details - K852974

510(k) Number K852974 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 15, 1985
Decision Date October 24, 1985
Days to Decision 101 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
6d faster than avg
Panel avg: 107d · This submission: 101d
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 K852974.
SONOLAYER-L, SAL-77A
K852090 · Toshiba Medical Systems · Dec 1985
NEW OPTIONAL PROBES FOR SSA-90A
K852159 · Toshiba Medical Systems · Dec 1985
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
K853755 · Victoreen, Inc. · Nov 1985
SONOLAYER-L SAL-32B
K851240 · Toshiba Medical Systems · Sep 1985
CONVEX PROBE, PVE-393M
K851526 · Toshiba Medical Systems · Sep 1985
SONOLAYER-V, SSA-90A
K851036 · Toshiba Medical Systems · Sep 1985