# K131873: Ndohd High Definition Imaging System (Ndohd)

- Pathway: 510(k) (Traditional)
- Applicant: MethodSense, Inc.
- Decided: Sep 25, 2013 after 93 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
Longest line of descent: 1 generation back to K991738 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991738: Digital Video Recording System, Kay Elemetrics Corp. (1999) Summary page 1.

## Indications for use
The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

Source page: https://510kreport.com/device/K131873
Methodology: https://510kreport.com/methodology