Cleared Traditional

K844293 - AUTO DII MULTI FREQUENCY

K844293 is an FDA 510(k) clearance for AUTO DII MULTI FREQUENCY, manufactured by Technicare Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K844293 · Technicare Corp. · Radiology device
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Feb 1985
Decision
100d
Days
Class 2
Risk

K844293 is an FDA 510(k) clearance for the AUTO DII MULTI FREQUENCY. 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 Technicare Corp. (Englewood, US). The FDA issued a Cleared decision on February 13, 1985 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicare Corp. devices

FDA 510(k) Submission Details - K844293

510(k) Number K844293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1984
Decision Date February 13, 1985
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K844293.
DOPPLER UNIT, SDS-100A
K863577 · Toshiba Medical Systems · Feb 1987
TECA MF-20 MICROVASCULAR DOPPLER
K850071 · Teca, Inc. · Apr 1985
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
ACCESS SCANHEADSS
K840953 · Advanced Technology Laboratories, Inc. · Jun 1984