Cleared Traditional

VISIONLINK INTERFILE CONVERSION SOFTWARE (K933372) - FDA 510(k) Clearance

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

K933372 · Evergreen Technologies, Inc. · Radiology device
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Nov 1993
Decision
115d
Days
Class 2
Risk

K933372 is an FDA 510(k) clearance for the VISIONLINK INTERFILE CONVERSION SOFTWARE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Evergreen Technologies, Inc. (Castine, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Evergreen Technologies, Inc. devices

Submission Details

510(k) Number K933372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date November 01, 1993
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K933372.
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
K942146 · Siemens Medical Solutions USA, Inc. · Sep 1994
QUANTITATIVE HEART
K940236 · Siemens Medical Solutions USA, Inc. · May 1994
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
GCA-7200A
K931297 · Toshiba America Medical Systems, In.C · Jul 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993
MAXXUS
K924498 · GE Medical Systems · Dec 1992