Cleared Special

K231833 - Biograph Vision.X and Biograph Vision.X Edge (FDA 510(k) Clearance)

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

K231833 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
21d
Days
Class 2
Risk

K231833 is an FDA 510(k) clearance for the Biograph Vision.X and Biograph Vision.X Edge. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on July 13, 2023 after a review of 21 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 K231833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date July 13, 2023
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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
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