Cleared Special

K043524 - ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

K043524 is an FDA 510(k) clearance for ULTRASOUND SCANNER PRO FOCUS, manufactured by B & K Medical A/S. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 24-day FDA review.

K043524 · B & K Medical A/S · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
24d
Days
Class 2
Risk

K043524 is an FDA 510(k) clearance for the ULTRASOUND SCANNER PRO FOCUS, MODEL 2202. 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 B & K Medical A/S (Herlev, DK). The FDA issued a Cleared decision on January 13, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K043524

510(k) Number K043524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date January 13, 2005
Days to Decision 24 days
Submission Type Special
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
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 1178
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K043524.
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K043524 · ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
Download PDF FDA Summary B & K Medical A/S