Faxitron VisionCT
FDA 510(k) K173309 · Faxitron Bioptics, LLC
510(k) numberK173309
Submission
- Device name
- Faxitron VisionCT
- Applicant
- Faxitron Bioptics, LLC
Tucson, AZ, US - Received
- October 18, 2017
- Decision date
- May 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K202713 | TrueView 100 ProMWP · Traditional | Compai Healthcare (Shenzhen) Co.,Ltd | 11/18/2020SE |
| K200756 | Kubtec Mozart SupraMWP · Traditional | Kub Technologies, Inc. | 06/12/2020SE |
| K192939 | Volumetric Specimen ImagerMWP · Traditional | Clarix Imaging | 12/27/2019SE |
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Questions and answers
When was Faxitron VisionCT cleared by the FDA?
Faxitron VisionCT (K173309) received a 510(k) decision of Substantially Equivalent on May 9, 2018, 203 days after the submission was received.
What is the product code of K173309?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.