Cleared Traditional

K192196 - Medical Radiation Dosimetry System micr...

K192196 is the FDA 510(k) clearance for Medical Radiation Dosimetry System micr... by Landauer. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K192196 · Landauer · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
136d
Days
Class 2
Risk

K192196 is an FDA 510(k) clearance for the Medical Radiation Dosimetry System microSTARii. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Landauer (Glenwood, US). The FDA issued a Cleared decision on December 27, 2019 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Landauer devices

Submission Details

510(k) Number K192196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2019
Decision Date December 27, 2019
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 312
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K192196.
Beamscan MR
K191646 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten · Feb 2020
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
K192377 · Varian Medical Systems, Inc. · Feb 2020
AlignRT Plus
K193431 · Vision Rt, Ltd. · Jan 2020
Elekta Unity
K192482 · Elekta Limited · Dec 2019
Synergy Platform, Synergy, Infinity, VersaHD
K192242 · Elekta Limited · Nov 2019
IDENTIFY
K192968 · Varian Medical Systems, Inc. · Nov 2019