# K093371: Model DGH 6000 Scanmate a

- Pathway: 510(k) (Traditional)
- Applicant: Dgh Technology, Inc.
- Decided: Apr 5, 2010 after 158 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
Longest line of descent: 1 generation back to K872726 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872726: DGH-3000A  a-Scan, Dgh Technology, Inc. (1987) Summary page 2.
- K000554: Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket, Quantel Medical (2000) Summary page 2.

## Most influential descendants
- K171301: Scanmate Flex (2017), 0 descendants of its own

## Indications for use
The intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The intended use of the DGH 6006 transducer is the measurement of AL, AGO, LT of the human eye. The DGH 6006 transducer is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6006 transducer.

Source page: https://510kreport.com/device/K093371
Methodology: https://510kreport.com/methodology