Cleared Traditional

K802704 - SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.

K802704 is an FDA 510(k) clearance for SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR., manufactured by Cgr Medical Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K802704 · Cgr Medical Corp. · Radiology device
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Dec 1980
Decision
41d
Days
Class 2
Risk

K802704 is an FDA 510(k) clearance for the SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Cgr Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Cgr Medical Corp. devices

FDA 510(k) Submission Details - K802704

510(k) Number K802704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1980
Decision Date December 11, 1980
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 483
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K802704.
SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
K802708 · General Electric Co. · Jan 1981
SIEMENS PHO/SONIC ALPHA 1000
K802759 · Siemens Gammasonics, Inc. · Jan 1981
HP MODEL 77020A ULTRASOUND SYSTEM
K801954 · Hewlett-Packard Co. · Dec 1980
DATASON DB SYSTEM
K801986 · General Electric Co. · Nov 1980
MINIVISOR TERMINAL
K802263 · Organon Teknika Corp. · Oct 1980
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K802146 · Parker Laboratories, Inc. · Oct 1980