# K040913: Ngdi (Next Generation Diagnostic Instrument)

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb
- Decided: Jul 23, 2004 after 106 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955442 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984443: Orbscan, Technolas Perfect Vision GmbH (1999) Summary page 1.
- K012873: Documenting Laser Slit Lamp, DP 2010, Bausch & Lomb, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K010992: Zywave Wavefront Diagnostic System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
Indicated Use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye. Also indicated for the measurement and analysis of optical aberrations of the eye by use of wavefront technology.

Source page: https://510kreport.com/device/K040913
Methodology: https://510kreport.com/methodology