Cleared Special

K000567 - ULTRASOUND SCANNER TYPE 2102

K000567 is an FDA 510(k) clearance for ULTRASOUND SCANNER TYPE 2102, manufactured by B & K Medical A/S. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 16-day FDA review.

K000567 · B & K Medical A/S · Radiology device
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Mar 2000
Decision
16d
Days
Class 2
Risk

K000567 is an FDA 510(k) clearance for the ULTRASOUND SCANNER TYPE 2102. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B & K Medical A/S (Dk 2820 Gentofte, DK). The FDA issued a Cleared decision on March 9, 2000 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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.

View all B & K Medical A/S devices

FDA 510(k) Submission Details - K000567

510(k) Number K000567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date March 09, 2000
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

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 568
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