Cleared Traditional

K033774 - CT-MASS

K033774 is the FDA 510(k) clearance for CT-MASS by Medis Medical Imaging Systems BV. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K033774 · Medis Medical Imaging Systems BV · Radiology device
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Mar 2004
Decision
90d
Days
Class 2
Risk

K033774 is an FDA 510(k) clearance for the CT-MASS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Medis Medical Imaging Systems BV (Leiden, NL). The FDA issued a Cleared decision on March 2, 2004 after a review of 90 days - within the typical 510(k) review window.

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: 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 Medis Medical Imaging Systems BV devices

Submission Details

510(k) Number K033774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2003
Decision Date March 02, 2004
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 582
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K033774.
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · Philips Medical Systems (Cleveland), Inc. · Sep 2004
HITACHI PRESTO
K040902 · Hitachi Medical Systems America, Inc. · Apr 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665 · Siemens Medical Solutions USA, Inc. · Apr 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · Ge Medical Systems, LLC · Mar 2004
BRAIN PERFUSION OPTION
K033677 · Philips Medical Systems (Cleveland), Inc. · Feb 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · Philips Medical Systems (Cleveland), Inc. · Jan 2004