Cleared Traditional

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 (K852502) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852502 · Bruel & Kjaer Industri A/S · Radiology device
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Oct 1986
Decision
498d
Days
Class 2
Risk

K852502 is an FDA 510(k) clearance for the AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Bruel & Kjaer Industri A/S (Denmark, DK). The FDA issued a Cleared decision on October 23, 1986 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Bruel & Kjaer Industri A/S devices

Submission Details

510(k) Number K852502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date October 23, 1986
Days to Decision 498 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
391d slower than avg
Panel avg: 107d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 205
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K852502.
3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306
K863041 · Siemens Medical Solutions USA, Inc. · Nov 1986
3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305
K863043 · Siemens Medical Solutions USA, Inc. · Nov 1986
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
K863096 · Siemens Medical Solutions USA, Inc. · Nov 1986
COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF
K862151 · Hewlett-Packard Co. · Sep 1986
ULTRASOUND IMAGING SYSTEM MODEL 280 SL
K860697 · Johnson & Johnson Professionals, Inc. · Jul 1986
5.0 MHZ INTRAOPERATIVE ARRAY
K860123 · Siemens Medical Solutions USA, Inc. · Jul 1986