Cleared Traditional

PROCESS 100 ST (K833846) - FDA 510(k) Clearance

Class I Radiology device.

K833846 · Cgr Medical Corp. · Radiology device
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Dec 1983
Decision
92d
Days
Class 1
Risk

K833846 is an FDA 510(k) clearance for the PROCESS 100 ST. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Cgr Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Cgr Medical Corp. devices

Submission Details

510(k) Number K833846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date December 16, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 28
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K833846.
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985
SPX GENERATOR
K842348 · General Electric Co. · Aug 1984
ECCO GENERATOR
K811198 · Philips Medical Systems (Cleveland), Inc. · Jun 1981
VECTOR-100 X-RAY GENERATOR
K802996 · Philips Medical Systems (Cleveland), Inc. · Jan 1981
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
K802548 · General Electric Co. · Dec 1980