NEORAY DR 2520 DIGITAL IMAGING SYSTEM— 510(k) K083048
Substantially EquivalentPortavision Medical, LLC
FDA 510(k) clearance K083048 for NEORAY DR 2520 DIGITAL IMAGING SYSTEM, Substantially Equivalent on 2008-11-21. Applicant: Portavision Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Portavision Medical, LLC
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kenner, LA, US
Recent devices under product code IZL
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view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.