Cleared Traditional

ANGIOSCAN SPECTRUM ANALYZER (K812184) - FDA 510(k) Clearance

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

K812184 · Unigon Industries, Inc. · Cardiovascular device
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Sep 1981
Decision
37d
Days
Class 2
Risk

K812184 is an FDA 510(k) clearance for the ANGIOSCAN SPECTRUM ANALYZER. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Unigon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - the FDA cardiovascular device 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 Unigon Industries, Inc. devices

Submission Details

510(k) Number K812184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date September 09, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 11
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K812184.
SONOLINE SX ULTRASOUND SCANNER
K852739 · Siemens Medical Solutions USA, Inc. · Mar 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978