Cleared Traditional

MiniCAT 2D (K201825) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201825 · Xoran Technologies, LLC · Radiology device
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Nov 2020
Decision
141d
Days
Class 2
Risk

K201825 is an FDA 510(k) clearance for the MiniCAT 2D. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Xoran Technologies, LLC (Ann Arbor, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Xoran Technologies, LLC devices

Submission Details

510(k) Number K201825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2020
Decision Date November 20, 2020
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 118
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K201825.
MULTIX Impact
K203345 · Siemens Medical Solutions USA, Inc. · Jan 2021
MULTIX Impact C
K203340 · Siemens Medical Solutions USA, Inc. · Jan 2021
Apolo D / Apolo S
K202388 · Vmi Tecnologias Ltda · Dec 2020
YSIO X.pree
K201670 · Siemens Medical Solutions USA, Inc. · Oct 2020
Radiographic System Challenge X
K202293 · Sedecal., Sa. · Oct 2020
GXR-Series Diagnostic X-Ray System
K202572 · DRGEM Corporation · Sep 2020