Cleared Traditional

DELTAMANAGER (K933321) - FDA 510(k) Clearance

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

K933321 · Medimage, Inc. · Radiology device
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Nov 1993
Decision
110d
Days
Class 2
Risk

K933321 is an FDA 510(k) clearance for the DELTAMANAGER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Medimage, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 110 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 Medimage, Inc. devices

Submission Details

510(k) Number K933321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1993
Decision Date November 03, 1993
Days to Decision 110 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
3d slower than avg
Panel avg: 107d · This submission: 110d
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 K933321.
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