Cleared Traditional

K070077 - ULTRASOUND SCANNER PROFOCUS

K070077 is an FDA 510(k) clearance for ULTRASOUND SCANNER PROFOCUS, 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 56-day FDA review.

K070077 · B-K Medical Aps · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
56d
Days
Class 2
Risk

K070077 is an FDA 510(k) clearance for the ULTRASOUND SCANNER PROFOCUS, MODEL 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 March 5, 2007 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B-K Medical Aps devices

FDA 510(k) Submission Details - K070077

510(k) Number K070077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2007
Decision Date March 05, 2007
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 431
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K070077.
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K071314 · Siemens Medical Solutions USA, Inc. · May 2007
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
K071204 · C.R. Bard, Inc. · May 2007
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K070526 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2007
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
K063085 · Siemens Medical Solutions USA, Inc. · Nov 2006
VOLCANO S51 FAMILY OF IMAGING SYSTEMS
K061215 · Volcano Corporation · Aug 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
K061641 · Shimadzu Medical Systems · Jul 2006