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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 828
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K000567.
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K000695 · Ge Medical Systems, Inc. · Mar 2000
BABY FACE
K994385 · Sonora Medical Systems · Mar 2000
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
K000554 · Quantel Medical · Mar 2000
PR3 ULTRASOUND SYSTEM
K993978 · Carolina Medical, Inc. · Feb 2000
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
K000030 · Medison America, Inc. · Jan 2000
TERATECH, MODEL 2000 IMAGING IMAGING
K992505 · Teratech Corp. · Nov 1999
K000567 · ULTRASOUND SCANNER TYPE 2102
Download PDF FDA Summary B & K Medical A/S