Cleared Traditional

K943315 - ULTRASOUND SCANNER 2002

K943315 is an FDA 510(k) clearance for ULTRASOUND SCANNER 2002, manufactured by B&K Medical. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 578-day FDA review.

K943315 · B&K Medical · Radiology device
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Feb 1996
Decision
578d
Days
Class 2
Risk

K943315 is an FDA 510(k) clearance for the ULTRASOUND SCANNER 2002. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B&K Medical (Gentofte, DK). The FDA issued a Cleared decision on February 9, 1996 after a review of 578 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all B&K Medical devices

FDA 510(k) Submission Details - K943315

510(k) Number K943315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1994
Decision Date February 09, 1996
Days to Decision 578 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
471d slower than avg
Panel avg: 107d · This submission: 578d
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 438
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