Cleared Traditional

K052216 - SOMATOM DEFINITION

K052216 is an FDA 510(k) clearance for SOMATOM DEFINITION, manufactured by Siemens Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K052216 · Siemens Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
36d
Days
Class 2
Risk

K052216 is an FDA 510(k) clearance for the SOMATOM DEFINITION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Mavern, US). The FDA issued a Cleared decision on September 8, 2005 after a review of 36 days - a notably fast clearance cycle.

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: 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 Medical Systems, Inc. devices

FDA 510(k) Submission Details - K052216

510(k) Number K052216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2005
Decision Date September 08, 2005
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 636
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K052216.
ILUMA ORTHOCAT/DENTALCAT
K053046 · Imtec Corp. · Nov 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · Ge Healthcare · Oct 2005
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
K052447 · Analogic Corp. · Sep 2005
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
K052157 · Ge Medical Systems, LLC · Aug 2005
SYNGO CIRCULATION
K052029 · Siemens AG Medical Solutions · Aug 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833 · Toshiba America Medical Systems, In.C · Jul 2005