Cleared Traditional

K960044 - ULTRAMAX/MODEL NUMBER A1

K960044 is an FDA 510(k) clearance for ULTRAMAX/MODEL NUMBER A1, manufactured by Entlab OY. The device is a Class 2 Radiology device with product code LWI cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K960044 · Entlab OY · Radiology device
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Aug 1996
Decision
213d
Days
Class 2
Risk

K960044 is an FDA 510(k) clearance for the ULTRAMAX/MODEL NUMBER A1. Classified as Ultrasound, Sinus (product code LWI), Class II - Special Controls.

Submitted by Entlab OY (Richmond, CA). The FDA issued a Cleared decision on August 2, 1996 after a review of 213 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 Entlab OY devices

FDA 510(k) Submission Details - K960044

510(k) Number K960044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date August 02, 1996
Days to Decision 213 days
Submission Type Traditional
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
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWI Device Classification - Class 2, Special Controls

Product Code LWI Ultrasound, Sinus
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.