Cleared Traditional

CT GUIDE (TM) (K903622) - FDA 510(k) Clearance

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

K903622 · Radi Medical Systems AB · Radiology device
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Oct 1990
Decision
81d
Days
Class 2
Risk

K903622 is an FDA 510(k) clearance for the CT GUIDE (TM). Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on October 29, 1990 after a review of 81 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 Radi Medical Systems AB devices

Submission Details

510(k) Number K903622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1990
Decision Date October 29, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
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 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K903622.
CT HILIGHT ADVANTAGE II
K904971 · GE Medical Systems · Jan 1991
XPRESS
K903701 · Toshiba America Medical Systems, In.C · Nov 1990
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763 · General Electric Co. · Nov 1990
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
K902557 · Toshiba America Medical Systems, In.C · Aug 1990
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456 · Toshiba America Medical Systems, In.C · Mar 1990
TCT-300S - UPGRADE
K900233 · Toshiba America Medical Systems, In.C · Feb 1990