# K030719: Pentacam Scheimpflug Camera

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgerate GmbH
- Decided: Sep 16, 2003 after 193 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955442 (1996). 3 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991284: Anterior Eye-Segment Analysis System, Nidek, Inc. (1999) Summary page 1.

## Most influential descendants
- K111505: Rtvue Cam with Corneal Power Upgrade (2011), 8 descendants of its own
- K180660: Avanti (2018), 5 descendants of its own
- K152311: Pentacam AXL (2016), 3 descendants of its own
- K143086: VX120 Ophthalmic Diagnostic Device (2015), 3 descendants of its own
- K222166: SOLIX (2022), 1 descendant of its own

## Recalls of this device
- Jul 8, 2022 · Class II · Z-1674-2022: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

## Indications for use
The Pentacam is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: . corneal shape, analyse condition of the lens (opaque crystalline lens), 0 analyse the anterior chamber angle, 0 analyse anterior chamber depth, 0 analyse the volume of the anterior chamber, 0 analyse anterior or posterior cortical opacity, analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross slit imaging with densitometry, corneal thickness.

Source page: https://510kreport.com/device/K030719
Methodology: https://510kreport.com/methodology