Cleared Traditional

K770530 - CLEON IMAGER

K770530 is an FDA 510(k) clearance for CLEON IMAGER, manufactured by Union Carbide Corp.. The device is a Class 1 Radiology device with product code JAM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K770530 · Union Carbide Corp. · Radiology device
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Apr 1977
Decision
15d
Days
Class 1
Risk

K770530 is an FDA 510(k) clearance for the CLEON IMAGER. Classified as Scanner, Whole Body, Nuclear (product code JAM), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1330 - 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K770530

510(k) Number K770530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1977
Decision Date April 05, 1977
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

JAM Device Classification - Class 1, General Controls

Product Code JAM Scanner, Whole Body, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.