Cleared Traditional

K183272 - AI Rad Companion (Engine)

K183272 is the FDA 510(k) clearance for AI Rad Companion (Engine) by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K183272 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
70d
Days
Class 2
Risk

K183272 is an FDA 510(k) clearance for the AI Rad Companion (Engine). Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 1, 2019 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K183272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2018
Decision Date February 01, 2019
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K183272.
IRIS 1.0 System
K182643 · Intuitive Surgical · Feb 2019
PhantomMSK
K182332 · OrthoGrid Systems, Inc. · Feb 2019
Presero 3D Scanning System
K190074 · Certis Health · Feb 2019
MRCP+ v1.0
K183133 · Perspectum Diagnostics, Ltd. · Jan 2019
ProKnow DS
K182855 · Proknow, LLC · Jan 2019
AmCAD-UO
K180867 · Amcad Biomed Corporation · Dec 2018