# K973833: Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic, Beam Limiting Device, Manual

- Pathway: 510(k) (Traditional)
- Applicant: Dynarad Corp.
- Decided: Dec 30, 1997 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083048: Neoray DR 2520 Digital Imaging System (2008), 0 descendants of its own

## Indications for use
The DynaRad NEO is a General Purpose Mobile X-Ray System that is specifically optimized to operate within the Neo Natal environment. The maximum output is 70 kVp at 50 mA from a 115/220 VAC wall outlet

Source page: https://510kreport.com/device/K973833
Methodology: https://510kreport.com/methodology