Cleared Traditional

K132346 - ULTRASOUND SCANNER PRO FOCUS 2202

K132346 is an FDA 510(k) clearance for ULTRASOUND SCANNER PRO FOCUS 2202, manufactured by B-K Medical Aps. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K132346 · B-K Medical Aps · Radiology device
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Jan 2014
Decision
165d
Days
Class 2
Risk

K132346 is an FDA 510(k) clearance for the ULTRASOUND SCANNER PRO FOCUS 2202. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B-K Medical Aps (Herlev, DK). The FDA issued a Cleared decision on January 10, 2014 after a review of 165 days - an extended review cycle.

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: 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 B-K Medical Aps devices

FDA 510(k) Submission Details - K132346

510(k) Number K132346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2013
Decision Date January 10, 2014
Days to Decision 165 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 107d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 432
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