# K072766: Pvmed DDR 2520 Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Portavision Medical
- Decided: Dec 11, 2007 after 74 days
- Product code: IXK (System, Imaging, X-Ray, Electrostatic)
- Device class: 2
- Regulation: 21 CFR 892.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K803130 (1981). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 1.
- K904519: Agfa Diagnostic Center (Adc), Enhanced Imaging Technologies, Inc. (1991) Summary page 1.

## Indications for use
The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient

Source page: https://510kreport.com/device/K072766
Methodology: https://510kreport.com/methodology