# Pentacam Scheimpflug Camera

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pentacam-scheimpflug-camera-mxk>
- Manufacturer: [OCULUS Optikgeräte GmbH](https://devicerts.com/manufacturers/oculus-optikgerate-gmbh) (Germany)
- Name in the registry: PENTACAM SCHEIMPFLUG CAMERA
- Device class: Class II (US FDA)
- FDA product code: MXK

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Pentacam Scheimpflug Camera is a diagnostic imaging device classified as an Anterior Segment Analysis Device (FDA: K030719). It performs high-resolution, non-contact optical coherence tomography and Scheimpflug imaging of the cornea and anterior segment of the eye, enabling detailed assessment of corneal topography, thickness, and anterior chamber parameters. The device provides quantitative data for diagnosing and monitoring conditions such as keratoconus, corneal ectasia, and post-surgical evaluations.

The Pentacam Scheimpflug Camera is supplied as a reusable medical device intended for use in ophthalmic clinical settings, including hospitals, private practices, and research facilities. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The device is MRI-unsafe due to its electronic components and must be used in non-MRI environments. Authorised under FDA 510(k) clearance and MDR, it adheres to regulatory standards for Class II medical devices (FDA: Device Class 2).

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K030719 · decision 2003-09-16 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

- Z-1674-2022 · Class II · ongoing · initiated 2022-07-08: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

## Identifiers

- 510(k) Number: K030719 [FDA 510(k)]
- FDA product code: MXK [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 886.1850 [FDA 510(k)]
- Advisory committee: Ophthalmic [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Pentacam Scheimpflug Camera, OCULUS Optikgeräte GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/pentacam-scheimpflug-camera-mxk (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/pentacam-scheimpflug-camera-mxk.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pentacam-scheimpflug-camera-mxk
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.