Cleared Special

syngo.CT Extended Functionality (K221727) - FDA 510(k) Clearance

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

K221727 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
29d
Days
Class 2
Risk

K221727 is an FDA 510(k) clearance for the syngo.CT Extended Functionality. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 13, 2022 after a review of 29 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K221727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2022
Decision Date July 13, 2022
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 427
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K221727.
AI-Rad Companion (Pulmonary)
K213713 · Siemens Healthcare GmbH · Aug 2022
Medical image processing software
K220910 · Hangzhou Deepwise & League of PHD Technology Co., Ltd. · Aug 2022
Deep Learning Image Reconstruction
K220961 · Ge Healthcare Japan Corporation · Jul 2022
NAEOTOM Alpha, Scan&GO Software
K220814 · Siemens Medical Solutions USA, Inc. · Jul 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
K213504 · Canon Medical Systems Corporation · Jun 2022
SCENARIA View
K213829 · Fujifilm Healthcare Corporation · May 2022