Cleared Traditional

K844896 - DEL MAR AVIONICS 8300 SECTOR IMAGER SYS

K844896 is the FDA 510(k) clearance for DEL MAR AVIONICS 8300 SECTOR IMAGER SYS by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K844896 · Del Mar Avionics · Cardiovascular device
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Jun 1985
Decision
175d
Days
Class 2
Risk

K844896 is an FDA 510(k) clearance for the DEL MAR AVIONICS 8300 SECTOR IMAGER SYS. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Del Mar Avionics devices

Submission Details

510(k) Number K844896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 10, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K844896.
SONOLAYER S, SSH-65A
K854606 · Toshiba Medical Systems · Feb 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981