Submission Details
| 510(k) Number | K193207 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
K193207 - TaiChiA
(FDA 510(k) Clearance)
Aug 2020
Decision
261d
Days
Class 2
Risk
K193207 is an FDA 510(k) clearance for the TaiChiA, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Our United Corporation (Xi'An, CN). The FDA issued a Cleared decision on August 7, 2020, 261 days after receiving the submission on November 20, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.
Device Classification
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.5050 |
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