Cleared Traditional

K802979 - DIASONICS SMALL PARTS SCANNER

K802979 is an FDA 510(k) clearance for DIASONICS SMALL PARTS SCANNER, manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K802979 · Diasonics, Inc. · Radiology device
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Jan 1981
Decision
62d
Days
Class 2
Risk

K802979 is an FDA 510(k) clearance for the DIASONICS SMALL PARTS 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 Diasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1981 after a review of 62 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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K802979

510(k) Number K802979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1980
Decision Date January 22, 1981
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
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 794
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K802979.
DOPPLER IMAGING OPTION
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ACCESS SCANHEADSS
K840953 · Advanced Technology Laboratories, Inc. · Jun 1984
LS1000 ELECTRONIC FOCUS
K810118 · Philips Medical Systems (Cleveland), Inc. · Feb 1981
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX
K801972 · Advanced Technology Laboratories, Inc. · Oct 1980
RA-I
K781642 · Diasonics, Inc. · Oct 1978