Cleared Special

K243186 - Symbia Pro.specta Q3 (11364751) (FDA 510(k) Clearance)

Also includes:
Symbia Pro.specta X3 (11364752) Symbia Pro.specta X7 (11364753) Symbia Pro.specta VA30A Family

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243186 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
30d
Days
Class 2
Risk

K243186 is an FDA 510(k) clearance for the Symbia Pro.specta Q3 (11364751). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on October 30, 2024 after a review of 30 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. 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K243186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 30, 2024
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 469
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K243186.
uMI Panvivo (uMI Panvivo LS)
K260524 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2026
uMI Panvivo (uMI Panvivo)
K253564 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K254001 · Spectrum Dynamics Medical, Ltd. · Jan 2026
AnyScan 3.0 NM Scanner Family
K253844 · Mediso Medical Imaging Systems, Ltd. · Dec 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · Canon Medical Systems Corporation · Dec 2025
PennPET Explorer Positron Emission Tomograph
K251401 · Trustees of the University of Pennsylvania · Nov 2025