Cleared Traditional

K834306 - PHASIX-HIGH FREQUENCY GENERATOR

K834306 is an FDA 510(k) clearance for PHASIX-HIGH FREQUENCY GENERATOR, manufactured by Cgr Medical Corp.. The device is a Class 1 Radiology device with product code ITY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K834306 · Cgr Medical Corp. · Radiology device
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Dec 1983
Decision
55d
Days
Class 1
Risk

K834306 is an FDA 510(k) clearance for the PHASIX-HIGH FREQUENCY GENERATOR. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Cgr Medical Corp. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1760 - 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 - K834306

510(k) Number K834306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1983
Decision Date December 29, 1983
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

ITY Device Classification - Class 1, General Controls

Product Code ITY Assembly, Tube Housing, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1760
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 - ITY Assembly, Tube Housing, X-ray, Diagnostic

All 11
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