Cleared Special

K050297 - SOMATOM EMOTION 16

K050297 is an FDA 510(k) clearance for SOMATOM EMOTION 16, manufactured by Siemens Medical Solution, Inc. USA. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 22-day FDA review.

K050297 · Siemens Medical Solution, Inc. USA · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
22d
Days
Class 2
Risk

K050297 is an FDA 510(k) clearance for the SOMATOM EMOTION 16. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solution, Inc. USA (Malvern, US). The FDA issued a Cleared decision on March 1, 2005 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050297

510(k) Number K050297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date March 01, 2005
Days to Decision 22 days
Submission Type Special
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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 797
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K050297.
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K043469 · Siemens AG Medical Solutions · Feb 2005
SOMATOM RESPIRATORY GATING
K043086 · Siemens Medical Solutions USA, Inc. · Dec 2004
SOMATOM CARE CONTRAST CT
K043087 · Siemens Medical Solutions USA, Inc. · Dec 2004
K050297 · SOMATOM EMOTION 16
Download PDF FDA Summary Siemens Medical Solut…