Cleared Traditional

K201825 - MiniCAT 2D

K201825 is an FDA 510(k) clearance for MiniCAT 2D, manufactured by Xoran Technologies, LLC. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

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

FDA 510(k) Submission Details - K201825

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.

KPR Device Classification - Class 2, Special Controls

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 192
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