Cleared Special

K181279 - Ysio Max

K181279 is the FDA 510(k) clearance for Ysio Max by Siemens Medi Cal Solutions, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Special 510(k) pathway after a 29-day FDA review.

K181279 · Siemens Medi Cal Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
29d
Days
Class 2
Risk

K181279 is an FDA 510(k) clearance for the Ysio Max. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Malvern, US). The FDA issued a Cleared decision on June 13, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K181279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2018
Decision Date June 13, 2018
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 KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 164
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K181279.
GU60A, GU60A-65
K182622 · Samsung Electronics Co., Ltd. · Oct 2018
GC85A
K181629 · Samsung Electronics Co., Ltd. · Jul 2018
uDR 592h, uDR 596i
K181413 · Shanghai United Imaging Healthcare Co., Ltd. · Jun 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · Samsung Electronics Co., Ltd. · May 2018
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
K180663 · Livermoretech, Inc. · May 2018
Televere Podiatry X-Ray System HF
K180765 · Televere Systems, Inc. · Apr 2018