Cleared Traditional

K905198 - DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535

K905198 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, manufactured by Bruel & Kjaer. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K905198 · Bruel & Kjaer · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
281d
Days
Class 2
Risk

K905198 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Bruel & Kjaer (Naerum 2850, DK). The FDA issued a Cleared decision on August 28, 1991 after a review of 281 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Bruel & Kjaer devices

FDA 510(k) Submission Details - K905198

510(k) Number K905198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date August 28, 1991
Days to Decision 281 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 107d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1143
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K905198.
ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION
K940285 · Acuson Corp. · Apr 1994
SSH-140A FETAL DOPPLER SYSTEM
K931293 · Toshiba America Medical Systems, In.C · Feb 1994
CEREBROVASCULAR DIAGNOSTIC SYSTEM
K914862 · Medasonics, Inc. · Dec 1992
ESI-3000 ULTRASOUND SYSTEM
K904359 · Elscint, Inc. · Mar 1991
DOPPLER OPTION FOR PLATINUM
K902691 · Philips Medical Systems, Inc. · Jan 1991
CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM
K901329 · Advanced Technology Laboratories, Inc. · Nov 1990