Cleared Traditional

K042863 - SCENIUM

K042863 is an FDA 510(k) clearance for SCENIUM, manufactured by Siemens Molecular Imaging, Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K042863 · Siemens Molecular Imaging, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
58d
Days
Class 2
Risk

K042863 is an FDA 510(k) clearance for the SCENIUM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Molecular Imaging, Ltd. (Knoxville, US). The FDA issued a Cleared decision on December 15, 2004 after a review of 58 days - a notably fast clearance cycle.

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: 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 Siemens Molecular Imaging, Ltd. devices

FDA 510(k) Submission Details - K042863

510(k) Number K042863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date December 15, 2004
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

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 333
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K042863.
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · Cti Pet Systems, Inc. · Mar 2005
GE DISCOVERY VCT SYSTEM
K050559 · GE Medical Systems · Mar 2005
INFINIA LIGHTSPEED
K043381 · Ge Medical Systems F.I. Haifa · Dec 2004
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004
JETSTREAM WORKSPACE
K042880 · Adac Laboratories · Nov 2004
C-PET PLUS IMAGING SYSTEM
K042839 · Philips Medical Systems (Cleveland), Inc. · Oct 2004