Pvmed DDR 2520 Digital Imaging System
FDA 510(k) K072766 · Portavision Medical
510(k) numberK072766
Submission
- Device name
- Pvmed DDR 2520 Digital Imaging System
- Applicant
- Portavision Medical
Austin, TX, US - Received
- September 28, 2007
- Decision date
- December 11, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K133524 | Pvmed DDR 2430TMQB · Traditional | 04/16/2014SE |
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Questions and answers
When was Pvmed DDR 2520 Digital Imaging System cleared by the FDA?
Pvmed DDR 2520 Digital Imaging System (K072766) received a 510(k) decision of Substantially Equivalent on December 11, 2007, 74 days after the submission was received.
What is the product code of K072766?
The FDA product code is IXK – System, Imaging, X-Ray, Electrostatic, a Class II (moderate risk) device regulated under 21 CFR 892.1630.