# K991738: Digital Video Recording System

- Pathway: 510(k) (Traditional)
- Applicant: Kay Elemetrics Corp.
- Decided: Aug 13, 1999 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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
- K131873: Ndohd High Definition Imaging System (Ndohd) (2013), 0 descendants of its own

## Indications for use
The intended use of the DVRS is for viewing, acquiring, recording, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.

Source page: https://510kreport.com/device/K991738
Methodology: https://510kreport.com/methodology