Cleared Traditional

K060410 - ECHOHEART TRANSVAGINAL DOPPLER PROBE (FDA 510(k) Clearance)

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

K060410 · Summit Doppler Systems, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
53d
Days
Class 2
Risk

K060410 is an FDA 510(k) clearance for the ECHOHEART TRANSVAGINAL DOPPLER PROBE. Classified as Monitor, Heart Sound, Fetal, Ultrasonic (product code HEK), Class II - Special Controls.

Submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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 Summit Doppler Systems, Inc. devices

Submission Details

510(k) Number K060410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2006
Decision Date April 10, 2006
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEK Monitor, Heart Sound, Fetal, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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.