Faxitron Specimen Radiography System, Model MX-20
FDA 510(k) K072557 · Faxitron X-Ray Corp.
510(k) numberK072557
Submission
- Device name
- Faxitron Specimen Radiography System, Model MX-20
- Applicant
- Faxitron X-Ray Corp.
Wheeling, IL, US - Received
- September 11, 2007
- Decision date
- October 30, 2007
- 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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More from Cirdan Imaging Limited
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|---|---|---|
| K061361 | Faxitron Digital Radiography System, Model DX-50MWP · Traditional | 08/15/2006SE |
Questions and answers
When was Faxitron Specimen Radiography System, Model MX-20 cleared by the FDA?
Faxitron Specimen Radiography System, Model MX-20 (K072557) received a 510(k) decision of Substantially Equivalent on October 30, 2007, 49 days after the submission was received.
What is the product code of K072557?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.