Cleared Traditional

K173138 - Biim Diagnostic Ultrasound System

K173138 is an FDA 510(k) clearance for Biim Diagnostic Ultrasound System, manufactured by Biim Ultrasound AS. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K173138 · Biim Ultrasound AS · Radiology device
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Oct 2017
Decision
28d
Days
Class 2
Risk

K173138 is an FDA 510(k) clearance for the Biim Diagnostic Ultrasound System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Biim Ultrasound AS (Narvik, NO). The FDA issued a Cleared decision on October 27, 2017 after a review of 28 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 Biim Ultrasound AS devices

FDA 510(k) Submission Details - K173138

510(k) Number K173138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date October 27, 2017
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 487
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K173138.
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