Submission Details
| 510(k) Number | K072766 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2007 |
| Decision Date | December 11, 2007 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
PVMED DDR 2520 DIGITAL IMAGING SYSTEM
Dec 2007
Decision
74d
Days
Class 2
Risk
About This 510(k) Submission
K072766 is an FDA 510(k) clearance for the PVMED DDR 2520 DIGITAL IMAGING SYSTEM, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Portavision Medical (Austin, US). The FDA issued a Cleared decision on December 11, 2007, 74 days after receiving the submission on September 28, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.
Device Classification
| Product Code | IXK — System, Imaging, X-ray, Electrostatic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1630 |
Manufacturer
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