# K083048: Neoray DR 2520 Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Portavision Medical, LLC
- Decided: Nov 21, 2008 after 38 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973833 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043062: Model SR-130-D Portable Digital X-Ray System, Source-Ray, Inc. (2004) Summary page 1.
- K973833: Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic, Beam Limiting Device, Manual, Dynarad Corp. (1997) Summary page 1.

## Indications for use
The NeoRay DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy, it is specifically optimized to operate within the Neonatal environment. This device is not intended for mammography applications. 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/K083048
Methodology: https://510kreport.com/methodology