Cleared Traditional

K852947 - ADR 3160 W/PROBES PLB-308M

K852947 is the FDA 510(k) clearance for ADR 3160 W/PROBES PLB-308M by Advanced Technology Laboratories, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K852947 · Advanced Technology Laboratories, Inc. · Radiology device
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Jan 1986
Decision
179d
Days
Class 2
Risk

K852947 is an FDA 510(k) clearance for the ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bothell, US). The FDA issued a Cleared decision on January 6, 1986 after a review of 179 days - an extended review 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: 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 Advanced Technology Laboratories, Inc. devices

Submission Details

510(k) Number K852947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date January 06, 1986
Days to Decision 179 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
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K852947.
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