Cleared Traditional

K801972 - TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX

K801972 is an FDA 510(k) clearance for TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K801972 · Advanced Technology Laboratories, Inc. · Radiology device
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Oct 1980
Decision
65d
Days
Class 2
Risk

K801972 is an FDA 510(k) clearance for the TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX. 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 Advanced Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 65 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 Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K801972

510(k) Number K801972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date October 23, 1980
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
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 1115
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K801972.
LS1000 ELECTRONIC FOCUS
K810118 · Philips Medical Systems (Cleveland), Inc. · Feb 1981
ULTRASONIC STETHOSCOPE
K803246 · Sonicaid, Inc. · Jan 1981
DIASONICS SMALL PARTS SCANNER
K802979 · Diasonics, Inc. · Jan 1981
DOPPLER ULTRASONIC STETHOSCOPE
K801512 · Mountain Medical Equipment, Inc. · Aug 1980
RA-I
K781642 · Diasonics, Inc. · Oct 1978