# K042742: Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Oct 13, 2004 after 9 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 K912514 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012416: Confoscan 2 Confocal Microscope, Nidek Technologies Srl (2001) Summary page 1.
- (no number) slit-amp biomicroscope: named in the summary without a submission number

## Indications for use
Imaging and observation of the cellular layers of the anterior segment of the human eye, for the diagnosis and management of anterior segment diseases.

Source page: https://510kreport.com/device/K042742
Methodology: https://510kreport.com/methodology