Cleared Traditional

COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM (K981505) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981505 · Sonosite,Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
14d
Days
Class 2
Risk

K981505 is an FDA 510(k) clearance for the COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Sonosite,Inc. (Bothell, US). The FDA issued a Cleared decision on May 8, 1998 after a review of 14 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 Sonosite,Inc. devices

Submission Details

510(k) Number K981505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1998
Decision Date May 08, 1998
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 176
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