Neoray DR 2520 Digital Imaging System
FDA 510(k) K083048 · Portavision Medical, LLC
510(k) numberK083048
Submission
- Device name
- Neoray DR 2520 Digital Imaging System
- Applicant
- Portavision Medical, LLC
Kenner, LA, US - Received
- October 14, 2008
- Decision date
- November 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Neoray DR 2520 Digital Imaging System cleared by the FDA?
Neoray DR 2520 Digital Imaging System (K083048) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 38 days after the submission was received.
What is the product code of K083048?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.