Cleared Traditional

TaiChiA (K193207) - FDA 510(k) Clearance

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

K193207 · Our United Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
261d
Days
Class 2
Risk

K193207 is an FDA 510(k) clearance for the TaiChiA. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Our United Corporation (Xi'An, CN). The FDA issued a Cleared decision on August 7, 2020 after a review of 261 days - an extended review cycle.

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 Our United Corporation devices

Submission Details

510(k) Number K193207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2019
Decision Date August 07, 2020
Days to Decision 261 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
154d slower than avg
Panel avg: 107d · This submission: 261d
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 218
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K193207.
ExacTrac Dynamic
K203173 · Brainlab AG · Nov 2020
Cranial 4Pi Immobilization
K202050 · Brainlab AG · Aug 2020
The AIO Solution 3.0
K202068 · Orfit Industries NV · Aug 2020
ExacTrac Dynamic
K201276 · Brainlab AG · Jul 2020
Lollipop BiteBlock
K200652 · Radtec Medical Devices, Inc. · Jul 2020
ChartCheck
K201119 · Radformation, Inc. · Jun 2020