# K082016: GDX VCC with Ecc Software

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Aug 10, 2009 after 391 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012727 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941705: Nerve Fiber Analyzer, Carl Zeiss Meditec, Inc. (1994) Summary page 1.
- K030433: Stratusoct with RNFL Normative Database, Carl Zeiss Meditec, Inc. (2003) Summary page 1.

## Most influential descendants
- K093521: Gdxpro (2009), 0 descendants of its own

## Indications for use
The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy.

Source page: https://510kreport.com/device/K082016
Methodology: https://510kreport.com/methodology