Cleared Traditional

CT SCANNER DIAGNOSTIC CONSOLE, REMOTE (K772198) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K772198 · Varian Assoc., Inc. · Radiology device
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Dec 1977
Decision
6d
Days
Class 2
Risk

K772198 is an FDA 510(k) clearance for the CT SCANNER DIAGNOSTIC CONSOLE, REMOTE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1977 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K772198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1977
Decision Date December 05, 1977
Days to Decision 6 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 107d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 385
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K772198.
CT/T INDEPENDENT DIAGNOSTIC CENTER
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K780326 · General Electric Co. · Mar 1978
CT/T SYSTEM MODEL B7800A
K772317 · General Electric Co. · Jan 1978
TOMOGRAPHIC SYSTEM, COMPUTERIZED
K772123 · Philips Medical Systems (Cleveland), Inc. · Nov 1977
SYNERVIEW MODEL 6478
K770855 · Philips Medical Systems (Cleveland), Inc. · May 1977
CT/N-II SCANNER SYSTEM
K760688 · General Electric Co. · Oct 1976