Cleared Traditional

K801655 - AUTO SECTOR SCANNER

K801655 is an FDA 510(k) clearance for AUTO SECTOR SCANNER, manufactured by Unirad Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K801655 · Unirad Corp. · Radiology device
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Sep 1980
Decision
67d
Days
Class 2
Risk

K801655 is an FDA 510(k) clearance for the AUTO SECTOR SCANNER. 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 Unirad Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 67 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 Unirad Corp. devices

FDA 510(k) Submission Details - K801655

510(k) Number K801655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date September 26, 1980
Days to Decision 67 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 1114
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K801655.
ULTRASONIC STETHOSCOPE
K803246 · Sonicaid, Inc. · Jan 1981
DIASONICS SMALL PARTS SCANNER
K802979 · Diasonics, Inc. · Jan 1981
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX
K801972 · Advanced Technology Laboratories, Inc. · Oct 1980
DOPPLER ULTRASONIC STETHOSCOPE
K801512 · Mountain Medical Equipment, Inc. · Aug 1980
RA-I
K781642 · Diasonics, Inc. · Oct 1978