Cleared Traditional

SECTORTAC (K812606) - FDA 510(k) Clearance

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

K812606 · Echo Laboratories, Inc. · Radiology device
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Oct 1981
Decision
28d
Days
Class 2
Risk

K812606 is an FDA 510(k) clearance for the SECTORTAC. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Echo Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Echo Laboratories, Inc. devices

Submission Details

510(k) Number K812606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date October 13, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K812606.
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984
LS1000 ELECTRONIC FOCUS
K810118 · Philips Medical Systems (Cleveland), Inc. · Feb 1981