Faxitron Digital Radiography System, Model DX-50
FDA 510(k) K061361 · Faxitron X-Ray Corp.
510(k) numberK061361
Submission
- Device name
- Faxitron Digital Radiography System, Model DX-50
- Applicant
- Faxitron X-Ray Corp.
Wheeling, IL, US - Received
- May 16, 2006
- Decision date
- August 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K072557 | Faxitron Specimen Radiography System, Model MX-20MWP · Traditional | 10/30/2007SE |
Questions and answers
When was Faxitron Digital Radiography System, Model DX-50 cleared by the FDA?
Faxitron Digital Radiography System, Model DX-50 (K061361) received a 510(k) decision of Substantially Equivalent on August 15, 2006, 91 days after the submission was received.
What is the product code of K061361?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.