# K042501: Etg-4000 Optical Topography System

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Corp.
- Decided: Oct 12, 2004 after 28 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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 K011320 (2001). 1 ancestor in all.
67 later devices descend from it; 3 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011320: Etg-100 Optical Encephalography System, Hitachi Medical Systems America, Inc. (2001)

## Most influential descendants
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own
- K073036: Fore-Sight, MC-2000 Series (2008), 59 descendants of its own
- K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040 (2006), 59 descendants of its own
- K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) (2009), 58 descendants of its own
- K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) (2009), 57 descendants of its own

## Indications for use
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.

Source page: https://510kreport.com/device/K042501
Methodology: https://510kreport.com/methodology