Cleared Traditional

K033774 - CT-MASS (FDA 510(k) Clearance)

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

K033774 · Medis Medical Imaging Systems BV · Radiology device
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.

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
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · 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 88
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K033774.
Spectral CT Verida Family
K253649 · Philips Medical Systems Technologies , Ltd. · Mar 2026
CT Rembra RT
K252992 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
True Definition DL
K253686 · Ge Healthcare Japan Corporation · Mar 2026
Photonova Spectra, Photonova Spectra Select
K253520 · Ge Medical Systems, LLC · Mar 2026
SOMATOM X.cite
K253574 · Siemens Medical Solutions USA, Inc. · Mar 2026
Extremity CT Imaging System
K252249 · Mars Bioimaging , Ltd. · Mar 2026