# K913067: DGH-4000 a-Scan/Pachymeter

- Pathway: 510(k) (Traditional)
- Applicant: Dgh Technology, Inc.
- Decided: Jan 31, 1992 after 204 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K043287: Palmscan AP2000; Palmscan A2000; Palmscan P2000 (2004), 3 descendants of its own
- K063472: Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 (2007), 2 descendants of its own
- K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter (2013), 1 descendant of its own
- K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology (2015), 0 descendants of its own
- K012803: AL-2000 Combined Biometer and Pachymeter (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K913067
Methodology: https://510kreport.com/methodology